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

Primary Purpose

Retinal Vein Occlusion

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
Peripheral Laser
Sponsored by
Peter A Campochiaro, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring RVO, CRVO, BRVO, Horizon, Bravo, Cruise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • Retinal Consultants Medical Group
  • Southeast Retina
  • Ophthalmic consultants of Boston
  • Retina Associates of New Jersey
  • Retina Consultants of Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranibizumab as needed

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Serious Adverse Events.
Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.

Secondary Outcome Measures

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.
Mean Change in Retinal Thickness
Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).

Full Information

First Posted
August 31, 2010
Last Updated
November 27, 2013
Sponsor
Peter A Campochiaro, MD
Collaborators
The Macula Foundation, Inc., Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01198327
Brief Title
Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter A Campochiaro, MD
Collaborators
The Macula Foundation, Inc., Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
RVO, CRVO, BRVO, Horizon, Bravo, Cruise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab as needed
Arm Type
Experimental
Arm Description
Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
RBZ, lucentis
Intervention Description
Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.
Intervention Type
Other
Intervention Name(s)
Peripheral Laser
Other Intervention Name(s)
Laser
Intervention Description
Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.
Primary Outcome Measure Information:
Title
Incidence of Serious Adverse Events.
Description
Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.
Time Frame
24 mos
Secondary Outcome Measure Information:
Title
Mean Changes in Visual Acuity
Description
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.
Time Frame
24 mos from study baseline
Title
Mean Change in Retinal Thickness
Description
Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).
Time Frame
24 mos from study baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Campochiaro, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retinal Consultants Medical Group
City
Sacremento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Southeast Retina
City
Augusta,
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Ophthalmic consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2587
Country
United States
Facility Name
Retina Associates of New Jersey
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20630595
Citation
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.
Results Reference
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PubMed Identifier
20398941
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.
Results Reference
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Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion

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