Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
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|ClinicalTrials.gov Identifier: NCT00964795|
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-related Macular Degeneration||Drug: Intravitreal Aflibercept Injection 2mg||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||323 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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
- 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
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964795
|Study Director:||Clinical Trial Management||Regeneron Pharmaceuticals|