A Phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of Central Retinal Vein Occlusion

Phase 3

Completed

• Conditions: Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

• Registration Number: CTRI/2010/091/000010
• Lead Sponsor: Regeneron Pharmaceuticals Inc

Brief Summary

A Randomized, Double-Masked, Controlled Phase 3 Study with the primary objective to assess the efficacy of intravitreally (IVT) administered VEGF Trap-Eye compared to standard of care (observation [sham]) on best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol in subjects with macular edema secondary to CRVO. The study?s primary end point will be evaluated at Week 24. Please note that approximately 24 subjects from India will be enrolled from 11 different sites. The enrolment start in India is anticipated for the 31st March 2010 after DCGI approval is granted.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-13
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Inclusion Criteria 1.
• Center-involved macular edema secondary to CRVO with mean retinal thickness ≥ 250 μm in the central subfield on OCT 2.
• Adults ≥ 18 years 3.
• ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye 4.
• Men and women of childbearing potential must be willing to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study.
• Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives; IUD; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam or jelly.
• Willing, committed, and able to return for ALL clinic visits and complete all studyrelated procedures 6.
• Willingness to provide written informed consent.

Exclusion Criteria

• Exclusion Criteria 1.
• History of vitreoretinal surgery in the study eye or anticipated within the next 12 months following Day 1 2.
• Prior episode or bilateral manifestation of RVO 3.
• History of radial optic neurotomy or sheathotomy 4.
• Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye 5.
• CRVO disease duration > 9 months from date of diagnosis 6.
• Decrease in visual acuity due to causes other than CRVO 7.
• Only one functional eye even if that eye is otherwise eligible for the study 8.
• Ocular conditions with a poorer prognosis in the fellow eye than in the study eye 9.
• History or presence of AMD (dry or wet form) that is considered by the investigator to significantly affect central vision, DME, or diabetic retinopathy, defined as eyes of diabetic subjects with more than one microaneurysm outside the area of the vein occlusion (inclusive of both eyes) 10.
• Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1 11.
• Previous use of intraocular or periocular corticosteroids in the fellow eye within the 3 months prior to Day 1 12.
• Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) 13.
• Previous treatment with anti-angiogenic drugs in the fellow eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within the 3 months prior to Day 1 14.
• Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye 15.
• Vitreomacular traction or epiretinal membrane in either the study eye or fellow eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision 16.
• Ocular inflammation (including trace or above) or external ocular inflammation in the study eye 17.
• History of idiopathic or autoimmune uveitis in either eye 18.
• Structural damage to the center of the macula in either the study eye or fellow eye that is likely to preclude improvement in VA following the resolution of macular edema 19.
• Concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period 20.
• Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet (YAG) laser capsulotomy within the past 2 months, or any other intraocular surgery within the 3 months prior to Day 1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy measure is improvement in visual acuity versus baseline after 6 months of treatment.	Week 24

Secondary Outcome Measures

Name	Time	Method
1.visual acuity	2. Retinal thickness by OCT
3.Anterior segment neovascularization, neovascularization of the optic disc (NVD) or neovascularization of retina (NVE) requiring pan-retinal photocoagulation	Week 24
4.Change from baseline in NEI VFQ-25 total score, distance activities, near activities and vision dependency subscales	Week 24

Trial Locations

Locations (8)

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

Aravind Eye Hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

L V Prasad Eye Institute; 🇮🇳 India

Little Flower Hospital And Research Centre; 🇮🇳 23,, India

Narayana Nethralaya; 🇮🇳 Bangalore, KARNATAKA, India

Regional Institute of Ophthalmology; 🇮🇳 Kolkata, WEST BENGAL, India

Shroff Eye Hospital & Vision Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Vision Research Foundation (Sankara Nethralaya); 🇮🇳 Chennai, TAMIL NADU, India

Aditya Jyot Eye Hospital Pvt Ltd

🇮🇳Mumbai, MAHARASHTRA, India

Dr. S. Natarajan

Principal investigator

022-24177600

natyforu@yahoo.co.in