Phase 2
Completed N=159
Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
Macular Degeneration
Source: ClinicalTrials.gov NCT00320788 ↗
Enrolled (actual)
159
Serious AEs
—
Results posted
Mar 2012
Primary outcomePrimary: Mean Change of CR/LT From Baseline at Week 12 — -153.5; -75.6; -169.2; -56.3 μm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change of CR/LT From Baseline at Week 12 |
-153.5; -75.6; -169.2; -56.3; -139.8; -118.8 | — |
| SECONDARY Mean Percent Change of CR/LT From Baseline at Week 12 |
-32.4; -15.2; -33.2; -10.3; -21.1; -22.5 | — |
| SECONDARY Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12 |
8.8; 3.8; 8.3; 5.2; 2.6; 5.7 | — |
| SECONDARY Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12 |
18.8; 21.9; 25.8; 16.1; 9.7; 18.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00320788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.