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

Sponsor:	Peter A Campochiaro, MD
Collaborators:	The Macula Foundation, Inc. Genentech
Information provided by (Responsible Party):	Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01198327

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: RBZ	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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	25
Study Start Date:	August 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ranibizumab as needed Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.	Drug: RBZ Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart. Other Name: RBZ, lucentis

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

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:

Campochiaro PA, Hafiz G, Channa R, Shah SM, Nguyen QD, Ying H, Do DV, Zimmer-Galler I, Solomon SD, Sung JU, Syed B. Antagonism of Vascular Endothelial Growth Factor for Macular Edema Caused by Retinal Vein Occlusions: Two-Year Outcomes. Ophthalmology. 2010 Jul 12; [Epub ahead of print]

Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1. Epub 2010 Apr 15.

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
Last Updated:	December 6, 2011
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 May 23, 2012