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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
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 20, 2009
First Posted Date  ICMJE August 25, 2009
Results First Submitted Date  ICMJE August 28, 2014
Results First Posted Date  ICMJE March 23, 2015
Last Update Posted Date March 23, 2015
Study Start Date  ICMJE December 2009
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2009)
Assess long-term safety and tolerability via complete eye exam and collection of AE data [ Time Frame: 76 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2009)
Change in best corrected visual acuity from Day 1 through the end of the study [ Time Frame: 76 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: March 10, 2015)
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
Official Title  ICMJE An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-related Macular Degeneration
Intervention  ICMJE Drug: Intravitreal Aflibercept Injection 2mg
Other Name: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye
Study Arms  ICMJE 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.
Intervention: Drug: Intravitreal Aflibercept Injection 2mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2012)
323
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2009)
960
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00964795
Other Study ID Numbers  ICMJE VGFT-OD-0910
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Regeneron Pharmaceuticals
Original Responsible Party Avner Ingerman, M.D./Vice President, Ophthalmology Therapeutic Area Head, Regeneron Pharmaceuticals
Current Study Sponsor  ICMJE Regeneron Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bayer
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP