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

This study is ongoing, but not recruiting participants.

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: December 6, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2010

Last Updated Date

December 6, 2011

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01198327 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Retinal Vein Occlusion

Intervention ^ICMJE

Drug: RBZ

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

Other Name: RBZ, lucentis

Study Arm (s)

Experimental: Ranibizumab as needed

Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.

Intervention: Drug: RBZ

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01198327

Other Study ID Numbers ^ICMJE

NA_00040287

Has Data Monitoring Committee

Responsible Party

Peter A Campochiaro, MD, Johns Hopkins University

Study Sponsor ^ICMJE

Peter A Campochiaro, MD

Collaborators ^ICMJE

The Macula Foundation, Inc.
Genentech

Investigators ^ICMJE

Principal Investigator:

Peter A Campochiaro, MD

Johns Hopkins University

Information Provided By

Johns Hopkins University

Verification Date

November 2011

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

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