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

Retinal Vein Occlusion Clinical Trial

— RETAIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198327
• Other study ID #: NA_00040287
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2010
• Last updated: November 27, 2013
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

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

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

Locations

Country	Name	City	State
United States	Southeast Retina	Augusta,	Georgia
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Ophthalmic consultants of Boston	Boston	Massachusetts
United States	Retina Consultants of Houston	Houston	Texas
United States	Retinal Consultants Medical Group	Sacremento	California
United States	Retina Associates of New Jersey	Teaneck	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Peter A Campochiaro, MD	Genentech, Inc., The Macula Foundation, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Serious Adverse Events.	Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.	24 mos	Yes
Secondary	Mean Changes in Visual Acuity	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.	24 mos from study baseline	No
Secondary	Mean Change in Retinal Thickness	Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).	24 mos from study baseline	No