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, Inc.
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

August 31, 2010
November 27, 2013
August 2010
December 2012   (final data collection date for primary outcome measure)
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.
Incidence and severity of adverse events. [ Time Frame: 12 mos ] [ Designated as safety issue: Yes ]
Record the adverse events, both ocular and non-ocular to gather long-term safety data.
Complete list of historical versions of study NCT01198327 on ClinicalTrials.gov Archive Site
  • 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).
  • Evaluate functional outcome [ Time Frame: 12 mos ] [ Designated as safety issue: No ]
    Mean changes in visual acuity
  • Evaluate anatomic outcome [ Time Frame: 12 mos ] [ Designated as safety issue: No ]
    Mean change in OCT (Optical Coherence Tomography) retinal thickness
  • Evaluate treatment pattern [ Time Frame: 12 mos ] [ Designated as safety issue: No ]
    Ranibizumab treatment frequency
Not Provided
Not Provided
 
Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion
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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Retinal Vein Occlusion
  • 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
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.
Interventions:
  • Drug: ranibizumab
  • Other: Peripheral Laser

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01198327
NA_00040287
No
Peter A Campochiaro, MD, Johns Hopkins University
Peter A Campochiaro, MD
  • The Macula Foundation, Inc.
  • Genentech, Inc.
Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
Johns Hopkins University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP