Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

Phase 2

Completed

Interventions: Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Brief Summary: This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD.

The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Detailed Description: This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period.

After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.

Recruitment & Eligibility

Inclusion Criteria

Subfoveal CNV secondary to AMD.
Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT).
Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.

Exclusion Criteria

History of any vitreous hemorrhage within 4 weeks prior to Day 1.
Aphakia.
Significant subfoveal atrophy or scarring.
Prior treatment with the following in the study eye:
- Subfoveal thermal laser therapy.
- Submacular surgery or other surgical intervention for the treatment of AMD.
- Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1.
- Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).
- Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).
- Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).
- Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy.
- Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin).
Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.

Arm && Interventions

Group	Intervention	Description
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	-
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	-
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	-
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	-
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	-

Primary Outcome Measures

Name	Time	Method
Mean Change of CR/LT From Baseline at Week 12	Baseline and at Week 12	CR/LT measured in micrometers (µm); lower individual values represent better outcomes.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change of CR/LT From Baseline at Week 12	Baseline and at Week 12	CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12	Baseline and at week 12	Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12	At Week 12	Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning

Locations (18): Southeast Retina Center
🇺🇸
Augusta, Georgia, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
Charlotte Eye, Ear, Nose & Throat Asssociates
🇺🇸
Charlotte, North Carolina, United States
Associated Retina Consultants
🇺🇸
Phoenix, Arizona, United States
Retina Vitreous Associates Medical Group
🇺🇸
Beverly Hills, California, United States
Ophthalmic Consultants of Boston
🇺🇸
Boston, Massachusetts, United States
New England Retina Consultants PC
🇺🇸
West Springfield, Massachusetts, United States
Dean A. McGee Eye Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Black Hills Regional Eye Institute
🇺🇸
Rapid City, South Dakota, United States
Retina Northwest PC
🇺🇸
Portland, Oregon, United States
Retina-Vitreous Associates, P.C.
🇺🇸
Nashville, Tennessee, United States
Loma Linda University Health Care
🇺🇸
Loma Linda, California, United States
Midwest Eye Institute
🇺🇸
Indianapolis, Indiana, United States
Retina Diagnostic and Treatment Assoc., LLC
🇺🇸
Philadelphia, Pennsylvania, United States
Retina Centers, PC
🇺🇸
Tucson, Arizona, United States
Johns Hopkins Hospital School of Medicine
🇺🇸
Baltimore, Maryland, United States
Vitreoretinal Consultants Scurlock Tower Texas Medical Center
🇺🇸
Houston, Texas, United States
Medical Center Ophthamology
🇺🇸
San Antonio, Texas, United States