Back to Search
Start Over
Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR
- Source :
- Advances in Therapy
- Publication Year :
- 2020
- Publisher :
- Springer Science and Business Media LLC, 2020.
-
Abstract
- PURPOSE:To evaluate efficacy and safety of intravitreal injections of aflibercept (IVT-AFL) treat-and-extend (T&E) dosing regimens in treatment-naïve patients with exudative age-related macular degeneration (AMD).<br />METHODS:Adults aged at least 50 years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included. Patients received three monthly doses of IVT-AFL 2 mg. At week 16, patients were randomized 1:1 to IVT-AFL T&E with either 2- or 4-week adjustments. The primary endpoint was mean change in BCVA from baseline to week 52. Outcomes were assessed at weeks 52 and 96.<br />RESULTS:Baseline characteristics were comparable between the groups (n = 123 each). Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2- and 4-week groups, respectively. From baseline, mean change in BCVA was + 9.0 and + 8.4 letters (week 52) and + 7.6 and + 6.1 letters (week 96); mean change in central retinal thickness was - 134.4 µm and - 126.1 µm (week 52) and - 130.5 µm and - 125.3 µm (week 96). Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96. Over 96 weeks, mean number of injections was 10.4 (both groups). The safety profile of IVT-AFL was consistent with previous reports.<br />CONCLUSIONS:IVT-AFL administered using two different T&E regimens for treatment-naïve exudative AMD improved functional and anatomic outcomes at week 52 and outcomes were maintained to week 96. Outcomes were similar between the 2- and 4-week groups.<br />TRIAL REGISTRATION:ClinicalTrials.gov identifier, NCT02305238.
- Subjects :
- Male
030213 general clinical medicine
medicine.medical_specialty
genetic structures
Recombinant Fusion Proteins
Pharmacology toxicology
Visual Acuity
Angiogenesis Inhibitors
Exudative age-related macular degeneration
Treat and extend
Drug Administration Schedule
law.invention
Macular Degeneration
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
medicine
Humans
Treat-and-extend
Pharmacology (medical)
Aged
Original Research
Aflibercept
Aged, 80 and over
business.industry
General Medicine
Middle Aged
eye diseases
Rheumatology
Anti-vascular endothelial growth factor agents
Ophthalmology
Safety profile
Receptors, Vascular Endothelial Growth Factor
Treatment Outcome
030220 oncology & carcinogenesis
Intravitreal Injections
Female
sense organs
business
medicine.drug
Subjects
Details
- ISSN :
- 18658652 and 0741238X
- Volume :
- 37
- Database :
- OpenAIRE
- Journal :
- Advances in Therapy
- Accession number :
- edsair.doi.dedup.....05053aaf484c905c2eede7cb7607bc7d