Abstract | PURPOSE: DESIGN: Phase 3, open-label, randomized, visual acuity assessor-masked noninferiority and equivalence trial. PARTICIPANTS: METHODS: Patients were randomized 3:2 to treatment with the PDS with ranibizumab 100 mg/ml with fixed 24-week (Q24W) refill-exchanges (PDS Q24W) or intravitreal ranibizumab 0.5-mg injections every 4 weeks (monthly ranibizumab). MAIN OUTCOME MEASURES: Primary end point was change in best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter (letters) score from baseline averaged over weeks 36 and 40 (noninferiority margin,-4.5 letters; equivalence margin, ±4.5 letters). RESULTS: Archway enrolled 418 patients; 251 were randomized to and 248 received treatment with the PDS Q24W, and 167 were randomized to and received treatment with monthly ranibizumab. Baseline BCVA was 74.4 letters (PDS Q24W arm) and 75.5 letters (monthly ranibizumab arm; Snellen equivalent, 20/32). Adjusted mean change in BCVA score from baseline averaged over weeks 36 and 40 was +0.2 letters (standard error [SE], 0.5 letters) in the PDS Q24W arm and +0.5 letters (SE, 0.6 letters) in the monthly ranibizumab arm (difference, -0.3 letters; 95% confidence interval, -1.7 to 1.1 letters). PDS Q24W was both noninferior and equivalent to monthly ranibizumab. Of 246 PDS-treated patients assessed for supplemental ranibizumab treatment, 242 (98.4%) did not receive supplemental ranibizumab treatment before the first refill-exchange procedure, including 4 patients who discontinued treatment before the first refill-exchange procedure. Prespecified ocular adverse events of special interest were reported in 47 patients (19.0%) in the PDS Q24W arm and 10 patients (6.0%) in the monthly ranibizumab arm, which included, in the former arm, 4 (1.6%) endophthalmitis cases, 2 (0.8%) retinal detachments, 13 (5.2%) vitreous hemorrhages, 6 (2.4%) conjunctival erosions, and 5 (2.0%) conjunctival retractions. Most ocular adverse events in the PDS Q24W arm occurred within 1 month of implantation. CONCLUSIONS: Archway met its primary objective and PDS Q24W demonstrated noninferior and equivalent efficacy to monthly ranibizumab, with 98.4% of PDS-treated patients not receiving supplemental treatment in the first 24-week interval.
|
Authors | Nancy M Holekamp, Peter A Campochiaro, Margaret A Chang, Daniel Miller, Dante Pieramici, Anthony P Adamis, Christopher Brittain, Erica Evans, Derrick Kaufman, Katie F Maass, Shienal Patel, Shrirang Ranade, Natasha Singh, Giulio Barteselli, Carl Regillo, all Archway Investigators |
Journal | Ophthalmology
(Ophthalmology)
Vol. 129
Issue 3
Pg. 295-307
(03 2022)
ISSN: 1549-4713 [Electronic] United States |
PMID | 34597713
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Copyright | Copyright © 2021 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Angiogenesis Inhibitors
- VEGFA protein, human
- Vascular Endothelial Growth Factor A
- Ranibizumab
|
Topics |
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(administration & dosage)
- Choroidal Neovascularization
(diagnosis, drug therapy, physiopathology)
- Drug Delivery Systems
- Female
- Humans
- Male
- Middle Aged
- Ranibizumab
(administration & dosage)
- Treatment Outcome
- Vascular Access Devices
- Vascular Endothelial Growth Factor A
(antagonists & inhibitors)
- Visual Acuity
(physiology)
- Vitreous Body
(drug effects)
- Wet Macular Degeneration
(diagnosis, drug therapy, physiopathology)
|