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Purpose To evaluate the efficacy and safety of ranibizumab administered monthly for three months and then quarterly in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Design Phase IIIb, multicenter, randomized, double-masked, sham injection-controlled trial in patients with predominantly or minimally classic or occult with no classic CNV lesions. Methods Patients were randomized 1:1:1 to 0.3 mg ranibizumab (n = 60), 0.5 mg ranibizumab (n = 61), or sham (n = 63) treatment groups. The primary efficacy endpoint was mean change from baseline visual acuity (VA) at month 12. Results Mean changes from baseline VA at 12 months were −16.3, −1.6, and −0.2 letters for the sham, 0.3 mg, and 0.5 mg groups, respectively ( P ≤ .0001, each ranibizumab dose vs sham). Ranibizumab arrested CNV growth and reduced leakage from CNV. However, the treatment effect declined in the ranibizumab groups during quarterly dosing (e.g., at three months the mean changes from baseline VA had been gains of 2.9 and 4.3 letters for the 0.3 mg and 0.5 mg doses, respectively). Results of subgroups analyses of mean change from baseline VA at 12 months by baseline age, VA, and lesion characteristics were consistent with the overall results. Few serious ocular or nonocular adverse events occurred in any group. Conclusions Ranibizumab administered monthly for three months and then quarterly provided significant VA benefit to patients with AMD-related subfoveal CNV and was well tolerated. The incidence of serious ocular or nonocular adverse events was low.

PURPOSE: To investigate the effect of the combined treatment of photodynamic therapy and specific VEGF165 inhibition with pegaptanib sodium (Macugen; Eyetech Pharmaceuticals, Lexington, MA) on ocular neovascularization. METHODS: Photodynamic therapy's (PDT's) effects on the integrity of pegaptanib sodium were analyzed by HPLC, a VEGF165-binding assay, and a VEGF165-induced tissue factor gene expression assay. The effects of mono- or combined treatment on vessel growth and regression were determined in a murine corneal neovascularization model. The effects of combined treatment on vessel growth were also determined in a murine choroidal neovascularization model. RESULTS: PDT did not affect the chemical composition of pegaptanib sodium nor the efficacy of pegaptanib sodium in the inhibition of VEGF165 binding to Flt-1 and VEGF165-induced gene expression. In an animal model of effects on existing ocular neovascular lesions (corneal neovascularization), PDT monotherapy yielded an initial regression of these vessels, but there followed a rapid regrowth. In contrast, pegaptanib sodium monotherapy yielded little regression but potently abrogated further vessel growth. The combination of pegaptanib sodium and PDT resulted in the regression of the neovascular lesions, as observed with PDT alone, but also prevented significant vessel regrowth, leading to a significantly greater reduction in lesion size than did each monotherapy. In addition, there was a significantly greater effect of the combination of pegaptanib sodium and PDT on lesion size in choroidal neovascularization than with each monotherapy. Pretreatment with pegaptanib sodium appeared to decrease the efficacy of PDT-induced vessel regression in corneal neovascularization, and as such the enhanced efficacy over monotherapy when the agents were delivered simultaneously was not observed. CONCLUSIONS: Although the combined simultaneous treatment of ocular neovascularization with PDT and pegaptanib sodium may provide a more effective approach for the regression and overall treatment of CNV associated with AMD, the order of addition of these treatments may play a role in achieving optimal efficacy.

Objective To characterize the safety, tolerability, and pharmacokinetics of the pegylated anti-vascular endothelial growth factor (VEGF) aptamer pegaptanib sodium in subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). Design Prospective 2-cohort study: (1) open-label cohort and (2) randomized, double-masked, uncontrolled multicenter trial. Participants In the combined cohorts, 147 subjects with any angiographic subtype of subfoveal choroidal neovascularization secondary to AMD and best-corrected visual acuities (VAs) in the study eye of 20/40 to 20/320 and in the fellow eye of 20/800 or better received pegaptanib sodium. Intervention Subjects were randomized to receive intravitreous pegaptanib sodium (1 mg or 3 mg [3- and 10-fold higher than the 0.3-mg approved dose]) every 6 weeks for 54 weeks. Main outcome measures Safety assessments included blood chemistries, urinalyses, vital signs, electrocardiograms, serum antipegaptanib antibody assays, adverse events, VAs, and intraocular pressures. After the first, fourth, and eighth injections, serial blood samples were obtained for quantification of pegaptanib plasma concentrations. Results No antipegaptanib immunoglobulin G (IgG) or IgM antibodies were detected. Few systemic adverse events were noted. Mild or moderate ocular adverse events related to the injection procedure were reported in most patients. Pegaptanib did not accumulate in plasma after multiple doses; systemic exposures were similar after the first, fourth, and eighth doses. The mean apparent terminal half-life was 10 days. Evaluation of blood pressure (BP) and urine protein, both of which are known to be affected by systemic VEGF inhibition, indicated no evidence of a pegaptanib treatment effect on these parameters. Mean BP at the end of year 1 remained below 140 mmHg (systolic) and 90 mmHg (diastolic), levels considered hypertension by the American College of Cardiology. Conclusions At doses up to 10-fold higher than the 0.3-mg dose approved for the treatment of AMD, pegaptanib sodium was well tolerated, with no detectable clinical evidence of systemic VEGF inhibition (i.e., no clinically meaningful changes in proteinuria or mean BP) and no clinically relevant ocular inflammation. Most ocular adverse events were related to the injection procedure itself and were mild or moderate in severity.

The National Institute for Health and Clinical Excellence (NICE) has had to delay its final decision on two drugs for age related macular degeneration after mounting pressure from charities and healthcare professionals. NICE, which advises health authorities in England and Wales on the treatments to use on the NHS, issued preliminary guidance in June on the use of ranibizumab (marketed as Lucentis) and pegaptanib (Macugen) for the treatment of the disease. Both drugs are already available in Scotland. It argued that pegaptanib should not be used at all and that ranibizumab should be …

Intravitreous injection: retrospective study on 2028 injections and their side effects M. C. Angulo Bocco, A. Glacet-Bernard, A. Zourdani, G. Coscas, G. Soubrane Objective: To observe the tolerance of repeated intravitreous injections over the short and long term and to analyze their complications. Patients and methods: The clinical records of consecutive patients having one or several intravitreous injections between 2002 and 2007 were evaluated, for all indications except the treatment of endophthalmitis. Results: 2028 intravitreous injections were performed, mainly for age-related macular degeneration (n=1 192) or macular edema secondary to diabetes mellitus or retinal vein occlusion (n=41). The injected drug was triamcinolone acetonide 4 mg (339 injections), pegaptanib sodium 0.3 mg (1179 injections), and ranibizumab 0.3 (497 injections). The patients received 1-27 intravitreous injections per eye. The main complications were endophthalmitis (two after triamcinolone, 0.1% of the total group), pseudoendophthalmitis (two after triamcinolone, 0.1% of the total group), hypertony (7.69% of the total group, 13.78% after triamcinolone, 3.56% after pegaptanib, 1.21% after ranibizumab), including five cases of acute hypertony with transient light perception loss after ranibizumab, cataract (0.44% of total group), and macular hole (one patient after triamcinolone). No case of retinal detachment nor systemic complication was observed. Discussion: Most of the complications were observed with the use of nonfiltered triamcinolone. The incidence of endophtalmitis was considerably lower with increased experience and the use of a dedicated room for the injections. Repeated injections were locally well tolerated. Conclusion: With the strict respect of asepsis rules, intravitreous injection seems well tolerated over the short and long term.

Purpose To describe two cases of neovascular age-related macular degeneration (AMD) that progressed despite a single intravitreal injection of pegaptanib sodium (Macugen) six weeks earlier. Design Interventional case report. Methods A 62-year-old man and a 76-year-old woman with occult and minimally classic lesions, respectively, each received a single injection of intravitreal pegaptanib. Results Within six weeks of an intravitreal pegaptanib injection, the choroidal neovascularization (CNV) progressed. In one eye, the chronic occult lesion developed subfoveal classic CNV. In the other eye, the classic component of the minimally classic lesion tripled in size. Conclusions A single dose of intravitreal pegaptanib was not effective in these two patients at six weeks. This report reminds the ophthalmologist to consider obtaining a fluorescein angiogram during follow-up after an intravitreal pegaptanib injection to monitor CNV lesion characteristics, particularly if the visual acuity decreases.

OBJECTIVE: To evaluate the efficacy of a second year of pegaptanib sodium therapy in patients with neovascular age-related macular degeneration (AMD). DESIGN: Two concurrent, multicenter, randomized, double-masked, sham-controlled studies (V.I.S.I.O.N. [Vascular Endothelial Growth Factor Inhibition Study in Ocular Neovascularization] trials). PARTICIPANTS: Patients with all angiographic neovascular lesion compositions of AMD were enrolled. In combined analyses, 88% (1053/1190) were re-randomized at week 54, and 89% (941/1053) were assessed at week 102. INTERVENTIONS: At week 54, those initially assigned to pegaptanib were re-randomized (1:1) to continue or discontinue therapy for 48 more weeks (8 injections). Those initially assigned to sham were re-randomized to continue sham, discontinue sham, or receive 1 of 3 pegaptanib doses. MAIN OUTCOME MEASURES: Mean change in visual acuity (VA) over time and mean change in the standardized area under the curve of VA and proportions of patients experiencing a loss of > or =15 letters from week 54 to week 102; losing or =0, > or =1, > or =2, and > or =3 lines of VA; and progressing to legal blindness (20/200 or worse). RESULTS: In combined analysis, mean VA was maintained in patients continuing with 0.3-mg pegaptanib compared with those discontinuing therapy or receiving usual care. In patients who continued pegaptanib, the proportion who lost >15 letters from baseline in the period from week 54 to week 102 was half (7%) that of patients who discontinued pegaptanib or remained on usual care (14% for each). Kaplan-Meier analysis showed that patients continuing 0.3-mg pegaptanib for a second year were less likely to lose > or =15 letters than those re-randomized to discontinue after 1 year (P

Purpose To evaluate the short-term safety of systemic bevacizumab (Avastin, Genentech, Inc., South San Francisco, CA) and its effects on visual acuity (VA) and subfoveal choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration (AMD). Design Open-label, single-center, uncontrolled clinical study. Participants Age-related macular degeneration patients with subfoveal CNV (N = 9) and best-corrected VA letter scores of 70 to 20 (approximate Snellen equivalent, 20/40–20/400). Methods Patients were treated at baseline with an infusion of bevacizumab (5 mg/kg), followed by 1 or 2 additional doses given at 2-week intervals. Safety assessments were performed at all visits. Ophthalmologic evaluations included protocol VA measurements and ocular examinations, along with optical coherence tomography (OCT) imaging, fluorescein angiography, and indocyanine green angiography. Main outcome measurements Safety assessments were performed, along with assessments of changes from baseline in VA scores, OCT measurements, and angiographic lesion characteristics. Results There were no serious ocular or systemic adverse events identified. By 6 weeks, the only adverse event identified was a mild elevation of systolic blood pressure (BP) (+12 mmHg; P = 0.035), and this elevation was controlled by either changing or initiating antihypertensive medication. By 12 weeks, the elevation of systolic BP was no longer significant ( P = 0.51). In the study eyes, significant increases in VA were evident within 1 week of treatment, and by 12 weeks, the median and mean VA letter scores increased by 8 letters ( P = 0.011) and 12 letters ( P = 0.008), respectively. The median and mean central retinal thickness measurements decreased by 157 μm ( P = 0.008) and 177 μm ( P = 0.001), respectively. In the fellow eyes at 12 weeks, the median and mean VA letter scores increased by 27 letters ( P = 0.018) and 16 letters ( P = 0.012), and the median and mean central retinal thickness measurements decreased by 59 μm ( P = 0.028) and 92 μm ( P = 0.06). In all study eyes, angiography revealed a marked reduction or an absence of leakage from CNV. Conclusion Overall, bevacizumab therapy was well tolerated, with an improvement in VA, OCT, and angiographic outcomes. Although these preliminary results are promising, a randomized controlled clinical trial is necessary before concluding that systemic bevacizumab therapy is safe and effective for patients with neovascular AMD.

OLECULAR MEDICINE OFFERS PROMISE FOR THE preventionofvisionlosscausedbyocularneovascularization in diabetic retinopathy and exudative age-related macular degeneration (ARMD). During the past decade, significant advances have been made in angiogenesis research, such that the understanding about new vessel formation in disease has increased considerably. This knowledge has led to the development of numerous inhibitors of angiogenesis. Among a host of novel therapeutics for ocular neovascularization, 2 inhibitorsoftheangiogenicagentvascularendothelialgrowth factor (VEGF)—pegaptanib sodium and ranibizumab— are poised for imminent clinical application. However, the need for repeated intraocular injection of these agents and thepotentialforlocalandsystemicadverseeffectsmaypose hurdles for these emerging therapies. Conventional Treatments Have Limitations

To report 24-month vision and fluorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, Ga) in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD).

Age-related macular degeneration is the leading cause of irreversible visual loss in elderly patients. After photodynamic therapy, therapy targeting vascular endothelial growth factor (VEGF) therapy has become the gold standard for treating neovascular age-related macular degeneration. Although monthly intravitreal injections of anti-VEGF agents are the most promising treatment to improve and sustain vision, as-needed treatments were administered based on the monthly examinations mainly because of cost-effectiveness. However, as-needed treatments are considered reactive treatments that burden patients and doctors with required monthly examinations and potentially decrease the improved vision. To address this, the treat-and-extend regimen, a proactive treatment, has been advocated as individualized medicine. This article reviews the characteristics of currently available anti-VEGF agents and treatment strategies.

The authors presents the review of the literature concerning the pathogenesis, classification, risk factors as well as perspectives for the treatment of age-related macular degeneration (AMD). AMD is a progressive illness, which is the most common cause of blindness in developed countries. The degenerative changes associated with both forms (dry and wet AMD) occur in the central part of retina, the macula, but the exact aetiology is still not unclear. The pathogenesis of AMD includes: lipofuscine genesis, drusogenesis, and local inflammatory state, as well as neoangiogenesis. Multiple studies have assessed the role of genetic variants on AMD development and progression, especially with complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) genes, the two major susceptibility genes for AMD. The disease has been associated with light-induced oxidative damage, accumulation of cholesterol and other lipids, and has been linked to systemic factors such as smoking, hypertension and atherosclerosis. Also female gender, and a high body-mass index (BMI > 30) have been reported as the important demographic and environmental risk factors in AMD. The neovascular form of AMD is characterized by the formation of subretinal choroidal neovascularization (CNV) and is the cause of most cases of blindness in the elders. Currently, the only approved treatment for dry AMD is the use of AREDS formulation. In the near future, it is likely that the treatment of dry AMD will be a combination of different drugs that will target the different pathways involved in the pathogenesis and progression of dry AMD. Exudative AMD is treated through injections of anti-VEGF A drugs as pegaptanib or ranibizumab and bevacizumab, which are considered the standard drugs. Aflibercept, or VEGF Trap-eye, is a novel compound derived from the native VEGF receptor (VEGFR) that binds to all VEGF and VEGF-B isoforms as well as to PlGF. It may be considered an attractive alternative to other anti-VEGF agents.

To develop an injection technique that reduces drug loss occurring due to reflux and consequent subconjunctival bleb formation after standard intravitreal pegaptanib injection.Prospective interventional case series report. The 27-gauge needle is inserted obliquely via pars plana to create a valved wound. The rate of subconjunctival bleb formation is evaluated performing ultrasound biomicroscopy, (1/2)h after intravitreal drug delivery comparing standard (straight)with this new described injection technique (oblique) using Fisher's exact test.Eyes on which oblique injection technique was performed developed significantly less subconjunctival bleb than those treated with the standard technique. The rate of injection-related complications (retinal detachment, vitreous haemorrhage, traumatic cataract, and endophthalmitis) in our small series was similar between both groups.The use of this technique can result in reduced drug loss after intravitreal pegaptanib injection. Larger studies are needed to determine if the rate of complications associated with intravitreal injections, especially endophthalmitis, is lowered with this technique.

Purpose We assess the effect of intravitreal anti-VEGF injections on tonographic outflow facility. Methods Patients with age-related macular degeneration who had received unilateral intravitreal anti-VEGF injections were recruited into two groups, those with ≤10 and those with ≥20 total anti-VEGF injections. Intraocular pressure and tonographic outflow facility of injected and uninjected fellow eyes were measured and compared between groups. Risk factors for development of reduced outflow facility also were assessed. Results Outflow facility was 12% lower in the injected eyes of patients who received ≥20 anti-VEGF injections, compared to contralateral uninjected eyes (P = 0.02). In contrast, there was no facility reduction for patients with ≤10 anti-VEGF injections (P = 0.4). In patients with ocular hypertension in the uninjected eye (IOP > 21 mm Hg, n = 5), the outflow facility of injected eyes was on average 46% lower (P = 0.01) than in the uninjected fellow eyes. This was significantly greater than the difference observed in patients with IOP ≤ 21 mm Hg in the uninjected eye (P = 2 × 10-4). In patients with ocular hypertension in the injected eye (n = 6) the differences in facility and IOP between contralateral eyes were significantly greater than in patients with IOP ≤ 21 mm Hg in the injected eye (P = 2 × 10-4 and P = 7 × 10-4, respectively). Conclusions Chronic anti-VEGF injections significantly reduce outflow facility in patients with AMD. The greatest facility reduction is observed in patients with baseline ocular hypertension. Ophthalmologists who administer anti-VEGF injections should be aware of these findings and monitor patients closely for changes in IOP or evidence of glaucoma, especially in those with pre-existing ocular hypertension.

Patricia Udaondo1,2, Salvador Garcia-Delpech1,3, David Salom1,3, Maria Garcia-Pous1,3, Manuel Diaz-Llopis1,31Nuevo Hospital Universitario y Politecnico La Fe, Valencia, Spain; 2University Cardenal Herrera CEU, Valencia, Spain; 3Faculty of Medicine, University of Valencia, Valencia, SpainPurpose: To assess the efficacy of intravitreal Pegaptanib sodium (Macugen®) injection in the management of refractory macular edema secondary to branch retinal vein occlusion.Methods: This is a prospective, nonrandomized, interventional case series. Five eyes of five patients with macular edema refractory to either bevacizumab or triamcinolone were treated with intravitreal injection of Pegaptanib sodium.Results: After three months follow-up, both visual acuity and macular edema, measured by optical coherence tomography and fluorescence angiography, dramatically improved.Conclusion: Pegaptanib sodium is a safe and efficacy treatment for macular edema secondary to branch retinal vein occlusion.Keywords: Macugen®, BRVO, BCVA, pegaptanib sodium

In the last few years anti-vascular endothelial growth factor (VEGF) therapy has changed the paradigm in the treatment of neovascular age-related macular degeneration (ARMD). Besides, its potential use in the treatment of diabetic retinopathy and other possible proliferative vascular disorders has also shown promise. Clinical trial results have shown tremendous beneficial effect of ranibizumab in ARMD. Off-label use of bevacizumab has also shown similar benefit but long-term and clinical trial results do not exist. Some of the potential questions in the use of anti-VEGF are recurring cost, possible long-term effect on physiological function of VEGF and determination of endpoint of treatment. Overall, the use of anti-VEGF therapy in ocular angiogenesis has proven to be beneficial at least now.

Diabetic retinopathy (DR) is a major cause of blindness in Europe and North America, and the incidence is expected to increase in parallel with the rising incidence of diabetes mellitus. This article reviews the current state of knowledge of the epidemiology, clinical presentation and pathophysiology of DR and its principal associated complications, diabetic macular oedema (DME) and neovascularization, and then proceeds to the primary focus of clinical management. A series of major randomized controlled trials conducted over the past few decades has confirmed that tight glycaemic regulation is the most effective measure to reduce the risk of developing DR and to minimize the likelihood of its progression, and that control of blood pressure is also an important feature of preventive management. Laser-based therapies remain the cornerstone of treatment, with panretinal photocoagulation indicated for proliferative and severe nonproliferative DR and focal photocoagulation indicated for treatment of DME. For patients who do not benefit from these approaches, vitrectomy may provide therapeutic benefits. Medical therapies include two broad classes of agents: anti-inflammatory drugs and agents with molecular targets. The utility of oral anti-inflammatory drugs remains to be established, as dose-finding studies have yet to provide definitive conclusions. Intravitreal corticosteroids may be of value in specific circumstances, although adverse effects include cataract progression and elevated intraocular pressure. However, these complications appear to have been limited with new extended-release technologies. With respect to molecular targets, evidence has been adduced for the roles of vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF)-α and protein kinase C (PKC)-β2 in the pathogenesis of DR, and agents targeting these factors are under intense investigation. The role of VEGF in mediating pathological angiogenesis and vascular hyperpermeability has been best defined. Preliminary efficacy of pegaptanib and ranibizumab in the treatment of DME is being confirmed in additional clinical trials with these agents and with the off-label use of bevacizumab, another monoclonal antibody related to ranibizumab. Moreover, other agents targeting VEGF, as well as drugs directed against TNFα and PKC-β2, are under study. Evaluation of the ultimate utility of these approaches will await the efficacy and safety results of properly designed phase III trials.

Diabetic macular edema is the major cause of visual acuity impairment in diabetic patients. The exact etiopathogenesis is unknown and, currently, grid/focal retinal laser photocoagulation represents the recommended treatment. It has been demonstrated that vascular endothelial growth factor (VEGF) plays a key role in the pathogenesis of diabetic macular edema by mediating vascular permeability and accumulation of intracellular and extracellular fluid, and thereby represents an appealing candidate as a therapeutic target for the treatment of diabetic macular edema. The advent of intravitreal anti-VEGF drugs has opened up a new era for the management of diabetic macular edema. At present, three anti-VEGF substances are available for routine clinical use, ie, pegaptanib, ranibizumab, and bevacizumab. The aim of this review is to summarize the evidence supporting the use of ranibizumab in clinical practice. Most of the studies analyzed in this review are prospective, controlled clinical trials that have focused on documenting the therapeutic effect of ranibizumab and its safety, providing encouraging results.

Purpose To report the novel use of intravitreal pegaptanib sodium for the treatment of refractory cystoid macular edema (CME) following cataract extraction. Methods A 72-year-old man presented with decreased visual acuity in his right eye 8 months after uncomplicated phacoemulsification cataract extraction and intraocular lens implantation. His best-corrected visual acuity (BCVA) was 20/125 in the affected eye, and fundus examination revealed CME despite 6 months of oral and topical indomethacin therapy. Fluorescein angiography (FA) showed leakage in the central region with no signs of neovascularization, and optical coherence tomography (OCT) confirmed the diagnosis with thickening of the fovea. Because of his history of glaucoma, the patient chose to be treated with intravitreal pegaptanib sodium 0.3 mg. Results At the 1-week follow-up, BCVA was 20/25, and the FA and OCT revealed almost total resolution of the CME with no adverse sequelae. Six months postinjection, the patient's BCVA remained 20/25 with no recurrence of CME. Perimetry revealed a stable fixation within 4° with slight reduction of sensitivity. Conclusions Vascular endothelial growth factor inhibition with intravitreal pegaptanib sodium appears to be of benefit in the treatment of chronic refractory CME with improvement of visual acuity. Studies evaluating pegaptanib's use in this setting with long-term follow-up are warranted to confirm its efficacy and safety.

This observational study was performed to evaluate the efficacy and safety of intra-vitreal injections of pegaptanib during a 12-month follow-up period.Forty eyes (20 patients) affected by diabetic macular edema were monitored. Twenty were subjected to treatment, and 20 were controls. The treatment involved a cycle of three intravitreal injections of pegaptanib (0.3 mg every 6 weeks), at the end of which treated patients were submitted to a monthly follow-up for a period of 12 months. The aim was to evaluate the clinical condition of the eye after therapy and gauge the efficacy of the long-term use of this drug. Specific criteria were used to measure the efficacy and safety of pegaptanib. Regarding efficacy, we considered the following: an average improvement in the power of vision, or visual acuity, of →10 letters (2 lines), equivalent to an average logMAR score of →0.2, and a reduction in the central macular thickness of →250 μm. Regarding safety, we considered the occurrence of undesired eye and systemic side effects correlated to either the drug itself or the injection procedure.The logMAR score for the measurement of visual acuity at T3 (third intra-vitreal injection at week 13) with respect to T0 decreased from 0.7 ± 0.277 to 0.445 ± 0.216, suggesting an improvement, while the mean Early Treatment Diabetic Retinopathy Study (ETDRS) score increased from 25.75 ± 13.046 to 34.300 ± 11.770 letters. The central macular thickness was reduced from the initial value of 746.95 ± 293.601 to 334.050 ± 93.997 μm. In seven controls, we registered a worsening both in terms of visual acuity and macular thickness in some eyes, justifying a continuation of therapy in eight eyes of the control group.Pegaptanib proved to be efficacious and safe for the treatment of diabetic macular edema throughout the 12-month followup. To evaluate its long-term efficacy, further studies are required with larger numbers of patients and longer observational follow-up periods.