Macular Edema Secondary to Central Retinal Vein OcclusionPhase 3NCT00943072
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
A Phase 3 study testing VEGF Trap-Eye 2.0mg in people with Macular Edema Secondary to Central Retinal Vein Occlusion, run by Regeneron Pharmaceuticals at 61 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema Secondary to Central Retinal Vein Occlusion
- What is being tested?
- VEGF Trap-Eye 2.0mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 61 sitesin 5 countries
- Study dates
- Jul 2009to Apr 2012
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
61 sites in 5 countries.
61 sites in 5 countries
United States46 sites
Study site
Abilene, Texas, 79606
Study site
Altamonte Springs, Florida, 32701
Study site
Arcadia, California, 91007
Study site
Augusta, Georgia, 30909
Study site
Baltimore, Maryland, 21209
Study site
Beverly Hills, California, 90211
Study site
Boston, Massachusetts, 02114
Study site
Chicago, Illinois, 60612
Study site
Cleveland, Ohio, 44195
Study site
Fort Lauderdale, Florida, 33334
Study site
Fort Myers, Florida, 33907
Study site
Fort Myers, Florida, 33912
Study site
Fort Worth, Texas, 76102
Study site
Grand Rapids, Michigan, 49525
Study site
Hagerstown, Maryland, 21740
Study site
Houston, Texas, 77030
Study site
Jackson, Michigan, 48104
Study site
Kingston, Pennsylvania, 18704
Study site
La Jolla, California, 92037
Study site
Las Vegas, Nevada, 89135
Study site
Lincoln, Nebraska, 68506
Study site
Miami, Florida, 33143
Study site
Mountain View, California, 94040
Study site
Nashville, Tennessee, 37203
Study site
New London, Connecticut, 06320
Study site
Northfield, New Jersey, 08225
Study site
Oakland, California, 94609
Study site
Oklahoma City, Oklahoma, 73104
Study site
Palm Beach Gardens, Florida, 33410
Study site
Phoenix, Arizona, 85014
Study site
Phoenix, Arizona, 85020
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Portland, Oregon, 97210
Study site
Rapid City, South Dakota, 57701
Study site
Rochester, New York, 14620
Study site
Sacramento, California, 95841
Study site
Salem, Oregon, 97302
Study site
San Antonio, Texas, 78240
Study site
Toms River, New Jersey, 08755
Study site
Torrance, California, 90503
Study site
Towson, Maryland, 21204
Study site
Tucson, Arizona, 85704
Study site
West Columbia, South Carolina, 29169
Study site
Wichita, Kansas, 67214
Study site
Winston-Salem, North Carolina, 27157
Study site
Winter Haven, Florida, 33880
Canada6 sites
Study site
Halifax, Nova Scotia, B3H 2Y9
Study site
London, Ontario, N6A 4V2
Study site
Mississauga, Ontario, L4W 1W9
Study site
Toronto, Ontario, M4N 3M5
Study site
Vancouver, British Columbia, V5Z 3N9
Study site
Victoria, British Columbia, V8V 4X3
Israel4 sites
Study site
Kfar Saba, Israel, 44281
Study site
Petah Tikva, Israel, 49100
Study site
Rehovot, Israel, 76100
Study site
Tel Aviv, Israel, 64239
India3 sites
Study site
Bangalore, Karnataka, 560010
Study site
Hyderabad, A.p., 500034
Study site
Kolkata, West Bengal, 700073
About this study
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
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.
- Being tested
- VEGF Trap-Eye 2.0mg, Sham
- Keywords
- Macular edema, Retinal vein occlusion, CRVO, VEGF Trap-Eye, best-corrected visual acuity, Regeneron, COPERNICUS
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGF Trap-Eye 2.0mgBiological
Monthly intravitreal injection out to the Week 24 Primary endpoint
ShamDrug
Monthly sham intravitreal injection out to Week 24 Primary Endpoint
| Study group | Role | What they receive |
|---|---|---|
| VEGF Trap-Eye | Experimental | Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint Receives: Biological: VEGF Trap-Eye 2.0mg |
| Sham | Sham comparator | Monthly Sham IVT injection until Week 24 Primary Endpoint Receives: Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at Week 24
Secondary outcomes (4)
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.
Measured: Baseline and at Week 24
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
Measured: 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
Measured: 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.
Measured: Baseline and at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular Edema Secondary to Central Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943072
- Sponsor's protocol ID
- VGFT-OD-0819
- Status last verified
- Apr 2013
- First submitted
- 10 Jul 2009
- Last updated
- 27 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes