Retinal Vein OcclusionPhase 2NCT00088283
Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
A Phase 2 study testing pegaptanib sodium in people with Retinal Vein Occlusion, run by Eyetech Pharmaceuticals at 35 sites in United States.
Trial summary
Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- pegaptanib sodium
- How many people
- 90 participants
- Where
- 35 sitesUnited States
- Study dates
- May 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- CRVO must have occurred within the past 6 months and be associated with macular edema determined by OCT.
- Vision in the study eye corresponding to between approximately 20/50 to 20/400 and better than or equal to approximately 20/200 in the fellow eye.
Who cannot join
- Presence of signs of old branch retinal vein occlusion (BRVO) or CRVO in the study eye or any other retinal vascular disease including diabetic retinopathy.
- Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
- Prior pan retinal photocoagulation (PRP) or sector scatter photocoagulation.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Retina Research Institute of Texas, LLC
Abilene, Texas, 79606
Austin Retina Associates
Austin, Texas, 78705
New England Eye Center
Boston, Massachusetts, 02111
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114
Charlotte Eye, Ear, Nose and Throat Associates, P.A.
Charlotte, North Carolina, 28210
Retina Group of Washington
Chevy Chase, Maryland, 20815
The University of Chicago
Chicago, Illinois, 60637
The Cleveland Clinic
Cleveland, Ohio, 44195
Palmetto Retina Center
Columbia, South Carolina, 29204
Texas Retina Associates
Dallas, Texas, 75231
Kresge Eye Institute
Detroit, Michigan, 48201
Duke University Eye Center
Durham, North Carolina, 27710
Retina Group of Florida
Fort Lauderdale, Florida, 33334
Cumberland Valley Retina Center
Hagerstown, Maryland, 21740
New England Retina Associates
Hamden, Connecticut, 06518
VitreoRetinal Consultants
Houston, Texas, 77030
Macula-Retina-Vitreous Service
Indianapolis, Indiana, 46280
Eye Foundation of Kansas City
Kansas City, Missouri, 64108
Southeastern Retina Associates
Knoxville, Tennessee, 37909
Retina Associates of Cleveland Inc.
Lakewood, Ohio, 44107
Jules Stein Institute
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53705
Valley Retina Associates, P.A.
McAllen, Texas, 78503
Bascom Palmer Eye Institute
Miami, Florida, 33136
The Eye Institute
Milwaukee, Wisconsin, 53226
Retina Associates
New Orleans, Louisiana, 70155
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Lahey Clinic, The Eye Institute
Peabody, Massachusetts, 01960
Wills Eye Institute Retina Research
Philadelphia, Pennsylvania, 19107
Casey Eye Institute
Portland, Oregon, 97239
Associated Retinal Consultants
Royal Oak, Michigan, 48073
Orange County Retina Associates
Santa Ana, California, 92705
Retina Centers, P.C., Northwest Location
Tucson, Arizona, 85704
Retina Associates, SW
Tucson, Arizona, 85710
Vitreo-Retinal Consultants & Surgeons, P.A.
Wichita, Kansas, 67214
About this study
Official title: A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO
Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye.
The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a "pretend" injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).
This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a "pretend" injection.
Read the detailed description
This study will consist of 3 phases: a screening phase which will last up to two weeks, a confirmation phase which will last one day, and a randomization phase (the patient will be assigned by chance to a study group in this phase) which will last approximately 52 weeks.
- Conditions
- Retinal Vein Occlusion
- Being tested
- pegaptanib sodium
- Keywords
- CRVO, Central Retinal Vein Occlusion, RVO, Retinal Vein Occlusion
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegaptanib sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2004 (estimated)
- Study startMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Eyetech Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088283
- Sponsor's protocol ID
- EOP 1011B
- Status last verified
- Jan 2007
- First submitted
- 23 Jul 2004
- Last updated
- 19 Jan 2007
- Results posted
- No
Publications
Wroblewski JJ, Wells JA 3rd, Adamis AP, Buggage RR, Cunningham ET Jr, Goldbaum M, Guyer DR, Katz B, Altaweel MM; Pegaptanib in Central Retinal Vein Occlusion Study Group. Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. Arch Ophthalmol. 2009 Apr;127(4):374-80. doi: 10.1001/archophthalmol.2009.14.
PubMed 19365011
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO
- ClinicalTrials.gov ID
- NCT00088283
- Acronym / sponsor ID
- EOP 1011B
- Conditions
- Retinal Vein Occlusion
- Keywords
- CRVO, Central Retinal Vein Occlusion, RVO, Retinal Vein Occlusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Eyetech PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- May 2004
- First posted
- 26 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye.
The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a "pretend" injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).
This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a "pretend" injection.
Detailed description
This study will consist of 3 phases: a screening phase which will last up to two weeks, a confirmation phase which will last one day, and a randomization phase (the patient will be assigned by chance to a study group in this phase) which will last approximately 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CRVO must have occurred within the past 6 months and be associated with macular edema determined by OCT.
- Vision in the study eye corresponding to between approximately 20/50 to 20/400 and better than or equal to approximately 20/200 in the fellow eye.
Key exclusion criteria (3 listed)
- Presence of signs of old branch retinal vein occlusion (BRVO) or CRVO in the study eye or any other retinal vascular disease including diabetic retinopathy.
- Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
- Prior pan retinal photocoagulation (PRP) or sector scatter photocoagulation.
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 |
|---|---|---|
| pegaptanib sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2007.
- Derived from this study: PubMed 19365011Wroblewski JJ, Wells JA 3rd, Adamis AP, Buggage RR, Cunningham ET Jr, Goldbaum M, Guyer DR, Katz B, Altaweel MM; Pegaptanib in Central Retinal Vein Occlusion Study Group. Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. Arch Ophthalmol. 2009 Apr;127(4):374-80. doi: 10.1001/archophthalmol.2009.14.
- Sponsor's WebsiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegaptanib sodium in people with Retinal Vein Occlusion, run by Eyetech Pharmaceuticals at 35 sites in United States.
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 3 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 19 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088283, which also lists 1 linked publication.
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 19 Jan 2007; AzTrials last refreshed its copy on 6 Nov 2026.