Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
- Conditions
- Age - Related Macular Degeneration (AMD)
- Interventions
- Drug: Intravitreal Aflibercept Injection (IAI)
- Registration Number
- NCT01722045
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open label IAI Intravitreal Aflibercept Injection (IAI) -
- Primary Outcome Measures
Name Time Method Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF) Baseline to Week 100 Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF) Baseline to Week 100 Retinal fluid status was evaluated using spectral domain OCT on the study eye at every study visit. Last observation carried forward (LOCF) method was used to impute missing data.
Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF) At week 52 and At week 100 Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.
Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF) Baseline to Week 52 Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.
Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF) Baseline to Week 100 Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.
Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF) Baseline to Week 100 Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.