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Trial record 2 of 15 for:    Genentech Horizon

Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion (RETAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198327
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
The Macula Foundation, Inc.
Genentech, Inc.
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Drug: ranibizumab Other: Peripheral Laser Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

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.
Drug: ranibizumab
Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.
Other Name: RBZ, lucentis

Other: Peripheral Laser
Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.
Other Name: Laser

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Mean Change in Retinal Thickness [ Time Frame: 24 mos from study baseline ]
    Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198327

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United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Retinal Consultants Medical Group
Sacremento, California, United States, 95819
United States, Georgia
Southeast Retina
Augusta,, Georgia, United States, 30909
United States, Massachusetts
Ophthalmic consultants of Boston
Boston, Massachusetts, United States, 02114-2587
United States, New Jersey
Retina Associates of New Jersey
Teaneck, New Jersey, United States, 07666
United States, Texas
Retina Consultants of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Peter A Campochiaro, MD
The Macula Foundation, Inc.
Genentech, Inc.
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Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
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Responsible Party: Peter A Campochiaro, MD, Principal Investigator, Johns Hopkins University Identifier: NCT01198327    
Other Study ID Numbers: NA_00040287
First Posted: September 10, 2010    Key Record Dates
Results First Posted: January 13, 2014
Last Update Posted: January 13, 2014
Last Verified: November 2013
Keywords provided by Peter A Campochiaro, MD, Johns Hopkins University:
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents