Clinical Studies:
VIEW 1 Extension
Citation: Kaiser PK, Singer M, Tolentino M, Vitti R, Erickson K, Saroj N, Berliner AJ, Chu KW, Zhu X, Williams Liu Z, Clark WL. Long-term Safety and Visual Outcome of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration: VIEW 1 Extension Study. Ophthalmol Retina. 2017 Jul-Aug;1(4):304-313.
Key Points
- The VIEW 1 trial was a Phase III multicenter, double-masked, randomized, parallel group, active treatment-controlled trial in the United States assessing the safety and efficacy of aflibercept for exudative macular degeneration
- Vision gains with aflibercept during the initial 52 weeks of the VIEW 1 study were largely maintained through a median 116 weeks extension, with no new safety profile concerns
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Objective
To assess the long-term safety and vision change in patients who received intravitreal aflibercept injection (IAI) for neovascular age-related macular degeneration in an extension study after completing VIEW 1 trial.
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STUDY DESIGN
Prospective , multicenter, open-label, randomized, extension study. After the initial 96 weeks of the VIEW 1 study, patients were enrolled in the extension study through week 212
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DURATION
212 weeks total, 116 week extension beyond the original 96 weeks of the VIEW 1 study
STUDY SUBJECTS
Major inclusion criteria:
- Age ≥ 50 years with an active, subfoveal CNV lesion secondary to AMD (juxtafoveal lesions with leakage extending into the fovea were also included)
- CNV comprising at least 50% to total lesion size
- BCVA between 73 and 25 ETDRS letters (20/40-20/320 Snellen equivalent)
- Completion of the original VIEW 1 study
Major exclusion criteria:
- Prior treatment for exudative macular degeneration
- Subretinal hemorrhage >50% of total lesion area
- Scar, fibrosis, or atrophy involving the fovea
- Total lesion size >12 dd
- Subretinal hemorrhage in the study eye that involves the fovea
- Any history of diabetic retinopathy, diabetic edema, or other vascular diseases of the retina
RANDOMIZATION SCHEME AND INTERVENTIONS
Patients were randomized in a 1:1:1:1 ratio into one of the following treatment groups for the first 52 weeks:
- 0.5 mg aflibercept q4 weeks
- 2 mg aflibercept q4 weeks
- 2 mg aflibercept q8 weeks (after 3 initial monthly treatments)
- 0.5 mg ranibizumab q4 weeks
Then modified quarterly injections of the same regimen from weeks 52 to 96
Extension study patients (weeks 96 to 212) received 2mg aflibercept on a modified quarterly schedule followed by at least an every 8 week dosing
RESULTS
Study population
- VIEW 1 enrolled 1217 patients
- Extension study enrolled 323 patients
Primary Endpoint
- Vision gains from original VIEW 1 study (average 10.2 letter gain) was largely preserved through the extension study (7.1 letter gain from baseline).
Secondary Endpoints
- Mean number of injections received during the extension was 12.9 (range 1-41)
- 0.9% rate of endophthalmitis
- Overall incidence of arterial thromboembolic events in the trial was 6.2%
CONCLUSIONS
Aflibercept 2mg dosing regimen in the extension study was largely able to maintain the vision gains of the original VIEW 1 study, with no new safety concerns identified.