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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Intravitreal Aflibercept Injection 2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00964795

VGFT-OD-0910

Details and patient eligibility

About

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

Full 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.

Enrollment: 323 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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323 participants in 1 patient group

Open-label Intravitreal Aflibercept Injection

Experimental group

Description:

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.

Treatment:

Drug: Intravitreal Aflibercept Injection 2mg