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

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ClinicalTrials.gov Identifier: NCT01247220
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Macular Edema Branch Retinal Vein Occlusion Drug: Ranibizumab Procedure: Peripheral Laser Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : November 2010
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
  • Scatter Laser
Active Comparator: Ranibizumab
Drug: Ranibizumab
Intravitreal Ranibizumab 0.5 mg
Other Names:
  • Standard of Care
  • Intravitreal Anti-VEGF

Outcome Measures

Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 6 and 12 months ]
    ETDRS visual acuity

Secondary Outcome Measures :
  1. Number of Ranibizumab Injections [ Time Frame: 12 months ]
    Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in second six months of observation period

  2. Retinal Thickness [ Time Frame: 6 and 12 months ]
    central foveal thickness on optical coherence tomography

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247220

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

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
First Posted: November 24, 2010    Key Record Dates
Results First Posted: October 6, 2014
Last Update Posted: October 6, 2014
Last Verified: October 2014

Keywords provided by Ivan J. Suner, MD, Retina Associates of Florida, P.A.:
Macular Edema
Branch retinal vein occlusion

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents