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

NCT01247220 | Completed Phase 2 Results DMC

• 1 other identifier: 20101717
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Macular Edema; Branch Retinal Vein Occlusion

Keywords

Macular Edema; Branch retinal vein occlusion; Ranibizumab

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  ETDRS visual acuity

  6 and 12 months

Secondary Outcomes (2)

• Number of Ranibizumab Injections

  12 months

• Retinal Thickness

  6 and 12 months

Study Arms (2)

Peripheral Laser + Ranibizumab

EXPERIMENTAL

Angiography-directed peripheral laser + ranibizumab

Drug: Ranibizumab; Procedure: Peripheral Laser

Ranibizumab

ACTIVE COMPARATOR

Ranibizumab

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Intravitreal Ranibizumab 0.5 mg

Also known as: Standard of Care, Intravitreal Anti-VEGF

Peripheral Laser + Ranibizumab; Ranibizumab

Peripheral Laser PROCEDURE

Angiography-directed peripheral laser

Also known as: Experimental, Scatter Laser

Peripheral Laser + Ranibizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Retina Associates of Florida, P.A.: lead

Study Sites (1)

Retina Associates of Florida, P.A.

Tampa, Florida, 33609, United States

Location

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

Ranibizumab; Standard of Care

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; 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; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

small study size

Results Point of Contact

• Title: Ivan J. Suner, MD
• Organization: Retina Associates of Florida

ivansuner@gmail.com

813-875-6373

Study Officials

• Ivan J Suner, MD

  Retina Associates of Florida, P.A.

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 24, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 6, 2014
• Results First Posted: October 6, 2014

Record last verified: 2014-10

Locations

US (1)