REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study (Revolution)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ivan J. Suner, MD, Retina Associates of Florida, P.A.
ClinicalTrials.gov Identifier:
NCT01247220
First received: November 17, 2010
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated with improved vision results. There is a subgroup of patients with peripheral nonperfusion on ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment.

In this trial the investigators compare the gold standard of monthly ranibizumab injections with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography. Each group will have monthly injections for the first six months, then as needed by either visual acuity decrease or increased retinal thickness for the subsequent six months.

The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence tomography, and number of ranibizumab injections


Condition Intervention Phase
Macular Edema
Branch Retinal Vein Occlusion
Drug: Ranibizumab
Procedure: Peripheral Laser
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: REVOLUTIONARY: REtinal Vein OccLUsion Treatment With Scatter Laser Guided by Ultra Widefield angIOgraphy in combiNAtion With Ranibizumab Study Phase II

Resource links provided by NLM:


Further study details as provided by Retina Associates of Florida, P.A.:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    ETDRS visual acuity


Secondary Outcome Measures:
  • Number of Ranibizumab Injections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in second six months of observation period

  • Retinal Thickness [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    central foveal thickness on optical coherence tomography


Enrollment: 12
Study Start Date: November 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peripheral Laser + Ranibizumab
Angiography-directed peripheral laser + ranibizumab
Drug: Ranibizumab
Intravitreal Ranibizumab 0.5 mg
Other Names:
  • Standard of Care
  • Intravitreal Anti-VEGF
Procedure: Peripheral Laser
Angiography-directed peripheral laser
Other Names:
  • Experimental
  • Peripheral Laser
  • Scatter Laser
Active Comparator: Ranibizumab
Ranibizumab
Drug: Ranibizumab
Intravitreal Ranibizumab 0.5 mg
Other Names:
  • Standard of Care
  • Intravitreal Anti-VEGF

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be eligible if the following criteria are met:
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years

    • Disease related considerations:
    • Study eye with macular edema secondary to branch retinal vein occlusion characterized by:
  • Fovea-involved macular edema of less than 12 months peripheral nonperfusion defined as at least 5 disc areas of contiguous nonperfusion on ultra-widefield fluorescein angiography absence of macular traction on clinical exam, UWFA, and OCT.
  • Study eye with best corrected visual acuity between 20/40 (≤ 73 letters on ETDRS chart) and 20/320 (≥ 19 letters on ETDRS chart)
  • Other considerations
  • Patient able to complete all study visits

Exclusion Criteria:

  • Subjects who meet any of the following criteria will be excluded from this study:

    • 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.
    • Prior enrollment in the study
    • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
    • Participation in another simultaneous medical investigation or trial
    • Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months
    • Previous macular or panretinal scatter laser photocoagulation
    • Previous pars plana vitrectomy
    • Visually-significant significant cataracts as primary reason for vision loss
    • Myocardial infarction or cerebrovascular accident within 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247220

Locations
United States, Florida
Retina Associates of Florida, P.A.
Tampa, Florida, United States, 33609
Sponsors and Collaborators
Retina Associates of Florida, P.A.
Investigators
Study Chair: Ivan J Suner, MD Retina Associates of Florida, P.A.
  More Information

No publications provided

Responsible Party: Ivan J. Suner, MD, Director of Clinical Research, Retina Associates of Florida, P.A.
ClinicalTrials.gov Identifier: NCT01247220     History of Changes
Other Study ID Numbers: 20101717
Study First Received: November 17, 2010
Results First Received: October 1, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Associates of Florida, P.A.:
Macular Edema
Branch retinal vein occlusion
Ranibizumab

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Thrombosis
Vascular Diseases
Venous Thrombosis

ClinicalTrials.gov processed this record on October 23, 2014