Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2)

Phase 2/3

• Conditions: Macular Degeneration

• Registration Number: CTRI/2008/091/000087
• Lead Sponsor: Bayer

Brief Summary

This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America. (FPFV in India: 25.05.2008)

Detailed Description

Not available

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

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: -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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	52 Weeks

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in CNV area at Week 52 [ Time Frame: week 52	52 Weeks
The proportion of subjects who gain at least 15 letters of vision at Week 52	52 Weeks
Mean change from baseline in total NEI VFQ-25 score at Week 52	52 Weeks
Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52	52 Weeks

Trial Locations

Locations (12)

Aditya Jyot Eye Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Advance Eye Center; 🇮🇳 Chandigarh, CHANDIGARH, India

Aravind Eye Hospital; 🇮🇳 Madurai, TAMIL NADU, India

Dr. Shroff?s Charity Eye Hospital; 🇮🇳 Delhi, DELHI, India

Dr.R.P Center for Ophthalmic Sciences; 🇮🇳 Delhi, DELHI, India

L.V. Prasad Eye Institute; 🇮🇳 India

Little Flower Hospital Trust; 🇮🇳 P.B, No.-23,, India

Narayana Netralaya; 🇮🇳 Bangalore, KARNATAKA, India

Regional Institute Of Ophthalmlogy; 🇮🇳 Kolkata, WEST BENGAL, India

Retina Foundation; 🇮🇳 Ahmadabad, GUJARAT, India

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Aditya Jyot Eye Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr.S.Natarajan

Principal investigator

22-24177600

drdarshanag@yahoo.co.in