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Purpose: To explore safety and therapeutic efficacy of a topical ophthalmic triamcinolone acetonide-loaded liposome formulation (TA-LF) as primary therapy in patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO). Methods: Twelve eyes of 12 patients with ME secondary to BRVO were exposed to a topical instillation of 1 drop of TA-LF (TA 0.2%) 6 times a day for 12 weeks to evaluate safety and efficacy. Best corrected visual acuity (BCVA) intraocular pressure (IOP), slit lamp examination, and central foveal thickness (CFT) were analyzed at every visit. In addition, the morphology of TA-LF was analyzed using scanning electron microscopy (SEM) and transmission electron microscopy (TEM). Results: Patients presented a significant improvement of BCVA and CFT without significant IOP modification (P = 0.94). Treated eyes showed BCVA improvement from 40 ± 12.05 to 64.83 ± 15.97 letters and CFT reduction from 682.91 ± 278.60 to 271.58 ± 57.66 μm after 12 weeks of TA-LF therapy (P < 0.001). No adverse events, including IOP rising, were registered. SEM analysis of liposomal formulations showed that liposome (LP) size depends on its concentration. As the concentration of TA increased, the average size of LPs and the number of larger particles increased as well. TEM study displayed that LP formulation efficiently solubilizes TA crystals in nanoparticles and encapsulates them. Conclusion: LPs can function as nanocarriers of TA and they could be used as topical ophthalmic primary therapy instead of intravitreal drugs in patients with ME secondary to BRVO. [ABSTRACT FROM AUTHOR]

Purpose: To report tolerability, safety, and efficacy of a topical triamcinolone acetonide-loaded liposomes formulation (TA-LF) in targeting the macular area in patients with refractory pseudophakic cystoid macular edema (PCME).Methods: For tolerability, safety and efficacy evaluation, 12 eyes of 12 patients with refractory PCME were exposed to one drop of TA-LF (TA at 0.2%) every 2 h for 90 days or until best-corrected visual acuity (BCVA) was achieved. Intraocular pressure (IOP), slit lamp examination, and central foveal thickness (CFT) were analyzed at every visit.Results: Patients with refractory PCME under TA-LF therapy showed a significant improvement in BVCA and CFT without significant IOP modification (P = 0.94). On average CFT decreased to 206.75 ± 135.72 μm and BCVA improved to 20.08 ± 10.35 letters (P < 0.0005). BCVA was achieved at 10.58 ± 6.70 weeks (range 2-18). TA-LF was well tolerated in all cases. Neither ocular surface abnormalities nor adverse events were recorded.Conclusion: TA-LF was well tolerated and improved BCVA and CFT on patients with refractory PCME. [ABSTRACT FROM AUTHOR]

Purpose: The objective of this study was to determine the relationshipbetween APOE polymorphism and the severity of retinal hard exudates in Mexicanpatients with type 2 diabetes. Methods: We studied 36 patients withdiabetic retinopathy and 22 unrelated and apparently healthy age-matched individuals.Blood samples for DNA genotyping and lipid profile were taken. Genotypingof polymorphic APOE alleles was done after polymerase chain reaction amplificationof genomic DNA, digestion with HhaI, and agarose gel electrophoresis. Stereoscopic35° color fundus photographs were taken of seven standard fields. Diabeticretinopathy, macular edema and hard exudates were graded according to a standardizedprocedure. Results: The results showed that the lipid profile washigher but not statistically significant (p > 0.05) in e4 allele carriers,with the exception of total lipids (p > 0.05). The frequency of severe retinalhard exudates was higher in those ε4 allele carriers (p < 0.05). Thehigher frequency of visual impairment (VA < 0.5 Log MAR) in ε4 carriersshowed a tendency towards statistical significance (p = 0.057). Conclusion: Our results suggest that the ε4 allele of the ApoE gene is a potentialrisk factor for the severity of retinal hard exudates and visual loss in type2 diabetic Mexican patients with diabetic retinopathy. [ABSTRACT FROM AUTHOR]

Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA-loaded liposomes formulation (TALF) was designed to transport TA into the posterior segment of the eye when instilled on the ocular surface. To evaluate the safety, tolerability, and biological activity of TALF, an animal study and a phase I clinical assay were performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biological activity of the formulation. No inflammation, lens opacity, swelling, or increase in intraocular pressure were recorded after the instillation of TALF in any of the animal or clinical studies. Mainly, mild and transient adverse events such as dry eye and burning were reported. TALF significantly improves visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biological activity of TALF. It seems that TALF can be used topically to treat vitreous and retinal diseases that respond to TA such as DME, avoiding the use of corticosteroid IVTs and their associated hazards. [ABSTRACT FROM AUTHOR]