- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01198327
Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion (RETAIN)
November 27, 2013 updated by: Peter A Campochiaro, MD
Extended Follow-up of Patients With Macular Edema Due to bRanch rETinal Vein Occlusion (BRVO) or centrAl Retinal veIn occlusioN (CRVO) Previously Treated With Intravitreal Ranibizumab
This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in the HORIZON extension trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits.
It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery.
One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90211
- Retina-Vitreous Associates Medical Group
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Sacremento, California, United States, 95819
- Retinal Consultants Medical Group
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Georgia
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Augusta,, Georgia, United States, 30909
- Southeast Retina
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Massachusetts
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Boston, Massachusetts, United States, 02114-2587
- Ophthalmic Consultants of Boston
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New Jersey
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Teaneck, New Jersey, United States, 07666
- Retina Associates of New Jersey
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-
Texas
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Houston, Texas, United States, 77030
- Retina Consultants of Houston
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent and authorization of use and disclosure of protected health information
- Age greater than or equal to 18 years
- Completion of 12 months in BRAVO or CRUISE trials, with subsequent follow-up in the HORIZON extension study. Exit from HORIZON should be within 90 days of enrollment
Exclusion Criteria:
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
- Inability to comply with study or follow up procedures
- Participation in another simultaneous medical investigation or trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ranibizumab as needed
Intravitreal ranibizumab, .5mg
dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.
|
Intravitreal ranibizumab, .5mg
dose, PRN but not less than 21 days apart.
Other Names:
Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Serious Adverse Events.
Time Frame: 24 mos
|
Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.
|
24 mos
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Changes in Visual Acuity
Time Frame: 24 mos from study baseline
|
Mean changes in visual acuity.
Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart.
The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.
|
24 mos from study baseline
|
Mean Change in Retinal Thickness
Time Frame: 24 mos from study baseline
|
Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).
|
24 mos from study baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15.
- Campochiaro PA, Hafiz G, Channa R, Shah SM, Nguyen QD, Ying H, Do DV, Zimmer-Galler I, Solomon SD, Sung JU, Syed B. Antagonism of vascular endothelial growth factor for macular edema caused by retinal vein occlusions: two-year outcomes. Ophthalmology. 2010 Dec;117(12):2387-2394.e1-5. doi: 10.1016/j.ophtha.2010.03.060. Epub 2010 Jul 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
August 31, 2010
First Submitted That Met QC Criteria
September 9, 2010
First Posted (Estimate)
September 10, 2010
Study Record Updates
Last Update Posted (Estimate)
January 13, 2014
Last Update Submitted That Met QC Criteria
November 27, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Macular Degeneration
- Macular Edema
- Retinal Vein Occlusion
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- NA_00040287
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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