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

This study has been completed.
Sponsor:
Collaborators:
The Macula Foundation, Inc.
Genentech
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01198327
First received: August 31, 2010
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Retinal Vein Occlusion
Drug: ranibizumab
Other: Peripheral Laser
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Incidence of Serious Adverse Events. [ Time Frame: 24 mos ] [ Designated as safety issue: Yes ]
    Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.


Secondary Outcome Measures:
  • Mean Changes in Visual Acuity [ Time Frame: 24 mos from study baseline ] [ Designated as safety issue: No ]
    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.

  • Mean Change in Retinal Thickness [ Time Frame: 24 mos from study baseline ] [ Designated as safety issue: No ]
    Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).


Enrollment: 66
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198327

Locations
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
Investigators
Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Peter A Campochiaro, MD, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01198327     History of Changes
Other Study ID Numbers: NA_00040287
Study First Received: August 31, 2010
Results First Received: September 23, 2013
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
RVO
CRVO
BRVO
Horizon
Bravo
Cruise

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014