Abstract | Importance: Objective: Design, Setting, and Participants: A double-masked, multicenter randomized clinical trial of 322 Asian participants with symptomatic macular PCV confirmed by the Central Reading Center using indocyanine green angiography was conducted between August 7, 2013, and March 2, 2017. Interventions: Participants were randomized 1:1 to ranibizumab, 0.5 mg, and vPDT (n = 168; combination therapy group) or ranibizumab, 0.5 mg, and sham PDT (n = 154; monotherapy group). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT/ sham PDT on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions. Main Outcomes and Measures: Step 1 assessed whether combination therapy was noninferior (5-letter margin) to monotherapy for change in best-corrected visual acuity from baseline and superior in complete polyp regression. If noninferiority was established, step 2 assessed whether combination therapy was superior to monotherapy measured by best-corrected visual acuity change at month 12. Results: Baseline demographics of the 322 participants were comparable between the treatment groups. Mean (SD) age of the patients was 68.1 (8.8) years, and overall, 69.9% of the patients were men. At baseline, the overall mean best-corrected visual acuity and mean central subfield thickness were 61.1 letters and 413.3 μm, respectively. At 12 months, mean improvement from baseline was 8.3 letters with combination therapy vs 5.1 letters with monotherapy (mean difference, 3.2 letters; 95% CI, 0.4-6.1), indicating that combination therapy met the predefined criterion for noninferiority as well as being superior to monotherapy (P = .01). Combination therapy was also superior to monotherapy in achieving complete polyp regression at month 12 (69.3% vs 34.7%; P < .001). Over 12 months, the combination therapy group received a median of 4.0 ranibizumab injections compared with 7.0 in the monotherapy group. Vitreous hemorrhage was the only ocular serious adverse event (combination therapy group, 1 [0.6%]; monotherapy group, 3 [2.0%]). Conclusions and Relevance: After 12 months, combination therapy of ranibizumab plus vPDT was not only noninferior but also superior to ranibizumab monotherapy in best-corrected visual acuity and superior in complete polyp regression while requiring fewer injections. Combination therapy should be considered for eyes with PCV. Trial Registration: clinicaltrials.gov Identifier: NCT01846273.
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Authors | Adrian Koh, Timothy Y Y Lai, Kanji Takahashi, Tien Y Wong, Lee-Jen Chen, Paisan Ruamviboonsuk, Colin S Tan, Chrystel Feller, Philippe Margaron, Tock H Lim, Won Ki Lee, EVEREST II study group |
Journal | JAMA ophthalmology
(JAMA Ophthalmol)
Vol. 135
Issue 11
Pg. 1206-1213
(11 01 2017)
ISSN: 2168-6173 [Electronic] United States |
PMID | 28983556
(Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiogenesis Inhibitors
- Photosensitizing Agents
- Porphyrins
- Verteporfin
- Ranibizumab
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Topics |
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(administration & dosage)
- Choroid
(blood supply, pathology)
- Choroid Diseases
(diagnosis, drug therapy)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Fluorescein Angiography
- Follow-Up Studies
- Fundus Oculi
- Humans
- Injections, Intravenous
- Intravitreal Injections
- Male
- Middle Aged
- Photochemotherapy
(methods)
- Photosensitizing Agents
(administration & dosage)
- Polyps
(diagnosis, drug therapy)
- Porphyrins
(administration & dosage)
- Ranibizumab
(administration & dosage)
- Retrospective Studies
- Treatment Outcome
- Verteporfin
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