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OpenTrials
Completed

NCT Number: NCT01198327

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Retina-Vitreous Associates Medical Group, Beverly Hills, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.

Other names: RBZ, lucentis

Peripheral Laser

Other

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

Other names: Laser

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Peter A Campochiaro, MD

Other

Collaborators

  • Genentech, Inc.
  • The Macula Foundation, Inc.

Registry information

Official study 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

Acronym: RETAIN

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 10, 2010
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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