Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

Study Overview
=================
Brief Summary
-----------------
This is 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.

Official Title
-----------------
A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion

Conditions
-----------------
Macular Edema Secondary to Central Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Biological: VEGF Trap-Eye 2.0mg
* Drug: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye Exclusion Criteria: Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.) Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye CRVO disease duration > 9 months from date of diagnosis 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 Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VEGF Trap-Eye<br>Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint | Biological: VEGF Trap-Eye 2.0mg<br>* Monthly intravitreal injection out to the Week 24 Primary endpoint<br>|
| Sham Comparator: Sham<br>Monthly Sham IVT injection until Week 24 Primary Endpoint | Drug: Sham<br>* Monthly sham intravitreal injection out to Week 24 Primary Endpoint<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score | Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. | Baseline and at Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF) | Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. | Baseline and at Week 24 | 
| Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF |  | Baseline and at Week 24 | 
| Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks |  | Baseline to Week 24 | 
| Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF) | The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight. | Baseline and at Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular edema, Retinal vein occlusion, CRVO, VEGF Trap-Eye, best-corrected visual acuity, Regeneron, COPERNICUS