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

NCT01198327 | Completed Phase 3 Results

• 1 other identifier: NA_00040287
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 6

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.

Conditions

Retinal Vein Occlusion

Keywords

RVO; CRVO; BRVO; Horizon; Bravo; Cruise

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Adverse Events.

  Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.

  24 mos

Secondary Outcomes (2)

• Mean Changes in Visual Acuity

  24 mos from study baseline

• Mean Change in Retinal Thickness

  24 mos from study baseline

Study Arms (1)

Ranibizumab as needed

EXPERIMENTAL

Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.

Drug: ranibizumab; Other: Peripheral Laser

Interventions

ranibizumab DRUG

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

Also known as: RBZ, lucentis

Ranibizumab as needed

Peripheral Laser OTHER

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

Also known as: Laser

Ranibizumab as needed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter A Campochiaro, MD: lead
• The Macula Foundation, Inc.: collaborator
• Genentech, Inc.: collaborator

Study Sites (6)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Retinal Consultants Medical Group

Sacremento, California, 95819, United States

Location

Southeast Retina

Augusta, Georgia, 30909, United States

Location

Ophthalmic consultants of Boston

Boston, Massachusetts, 02114-2587, United States

Location

Retina Associates of New Jersey

Teaneck, New Jersey, 07666, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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 Dec;117(12):2387-2394.e1-5. doi: 10.1016/j.ophtha.2010.03.060. Epub 2010 Jul 13.

  PMID: 20630595 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15.

  PMID: 20398941 BACKGROUND

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Ranibizumab; zorubicin; Lasers

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Peter Campocahiro
• Organization: Wilmer Eye Institute

pcampo@jhmi.edu

410-955-5106

Study Officials

• Peter A Campochiaro, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 10, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 13, 2014
• Results First Posted: January 13, 2014

Record last verified: 2013-11

Locations

US (6)