Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)

Phase 3

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Intravitreal Aflibercept Injection 2mg

• Registration Number: NCT00964795
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.

Detailed Description

The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study.

Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.

Study Timeline

• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Study Start: 2009-12
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2014-08-28
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Results First Posted: 2015-03-23
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

• Participation in Study VGFT-OD-0605 through week 96.
• In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.

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Exclusion Criteria

• Presence of any condition that would jeopardize the patient's participation in this study.
• Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label Intravitreal Aflibercept Injection	Intravitreal Aflibercept Injection 2mg	Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD	Baseline (day 1) through end of treatment (Week 180)	The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).; Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs

Secondary Outcome Measures

Name	Time	Method
Change in BCVA Letter Score (mLOCF)	Baseline through Week 116	The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.; (mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward).