None listed
Conditions
Interventions
Intervention1: VEGF Trap-Eye: 2.0 mg VEGF Trap-Eye administered every 8 weeks (including one additional 2,0 mg dose at Week 4) during the first year. Thereafter a dose may be administered as frequentl
Sponsors
Bayer
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: -Signed informed consent. -Men and women ≥ 50 years of age. -Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. -ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters. -Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures. -Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: -Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins. -Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye. -Any prior treatment with anti-VEGF agents in the study eye. -Total lesion size >12 disc areas (30.5 mm², including blood, scars and neovascularization) as assessed by FA in the study eye. -Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV). -Scar or fibrosis making up >50% of the total lesion in the study eye. -Scar, fibrosis, or atrophy involving the center of the fovea in the study eye. - Presence of retinal pigment epithelial tears or rips involving the macula in the study eye. -History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye. -Presence of other causes of CNV in the study eye. -Prior vitrectomy in the study eye. -History of retinal detachment or treatment or surgery for retinal detachment in the study eye. -Any history of macular hole of stage 2 and above in the study eye. -Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection. -History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52Timepoint: 52 Weeks;Mean change from baseline in CNV area at Week 52 [ Time Frame: week 52Timepoint: 52 Weeks;Mean change from baseline in total NEI VFQ-25 score at Week 52Timepoint: 52 Weeks;The proportion of subjects who gain at least 15 letters of vision at Week 52Timepoint: 52 Weeks | — |
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS chart compared to baseline (ie, prevention of moderate vision loss)Timepoint: 52 Weeks | — |
Countries
India
Contacts
Public ContactDr. Manish Garg
Country Medical Director India
Outcome results
None listed