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

This study has been completed.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals Identifier:
First received: August 20, 2009
Last updated: March 10, 2015
Last verified: March 2015
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.

Condition Intervention Phase
Neovascular Age-related Macular Degeneration
Drug: Intravitreal Aflibercept Injection 2mg
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD [ Time Frame: 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:
  • Change in BCVA Letter Score (mLOCF) [ Time Frame: 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).

Other Outcome Measures:
  • Summary of Treatment Duration (Weeks) [ Time Frame: Baseline through end of treatment (Week 180) ]
    Treatment Duration = (last dose date - first dose date + 28)/7

  • Summary of Study Duration (Weeks) [ Time Frame: Baseline through end of treatment (Week 180) ]
    Study Duration = (last visit/ discontinuation date - first dose date + 28)/7

Enrollment: 323
Study Start Date: December 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label Intravitreal Aflibercept Injection
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.
Drug: Intravitreal Aflibercept Injection 2mg
Other Name: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye

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.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00964795

  Show 124 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT00964795     History of Changes
Other Study ID Numbers: VGFT-OD-0910
Study First Received: August 20, 2009
Results First Received: August 28, 2014
Last Updated: March 10, 2015

Keywords provided by Regeneron Pharmaceuticals:
Macular Degeneration
VEGF Trap-Eye
Best Corrected Visual Acuity

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases processed this record on April 26, 2017