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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00943072
- Acronym / sponsor ID
- VGFT-OD-0819
- Keywords
- Macular edema, Retinal vein occlusion, CRVO, VEGF Trap-Eye, best-corrected visual acuity, Regeneron, COPERNICUS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Jul 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VEGF Trap-Eye | Experimental | Biological: VEGF Trap-Eye 2.0mgMonthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint |
| Sham | Sham comparator | Drug: ShamMonthly Sham IVT injection until Week 24 Primary Endpoint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEGF Trap-Eye 2.0mgMonthly intravitreal injection out to the Week 24 Primary endpoint | Biological | VEGF Trap-Eye |
| ShamMonthly sham intravitreal injection out to Week 24 Primary Endpoint | Drug | Sham |
Primary outcome
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score
Time frame: Baseline and at Week 24
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.
4 secondary outcomes
Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)
Time frame: Baseline and at Week 24
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
Time frame: 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
Time frame: Baseline to Week 24
Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)
Time frame: Baseline and at Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
61 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Canada, Israel, India, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score (time frame: Baseline and at Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.