Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)

NCT01225146 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: FVF4820s
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg in patients with ischemic CRVO who have been either previously treated with ranibizumab or treatment naïve.

Conditions

Ischemia; Retinal Vein Occlusion; Pathologic Processes; Retinal Diseases; Eye Diseases

Keywords

Ischemic; Central; Retinal; Vein; Occlusion; Ranibizumab; Lucentis; CRVO; ISCRVO

Outcome Measures

Primary Outcomes (1)

• Mean Change in logMAR

  Mean change from baseline in ETDRS NCVA.

  12 months.

Secondary Outcomes (5)

• Incidence and Severity of Adverse Events (Ocular and Non-ocular).

  12 months

• Neovascularization Development

  12 months

• Mean Change in Central Foveal Volume

  12 months

• Changes, by Disc Areas, of Capillary Non-perfusion in the Periphery

  12 months

• Goldman Visual Field Changes

  12 months

Study Arms (2)

Treatment Experienced (Cohort 1

ACTIVE COMPARATOR

Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s). Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria

Drug: ranibizumab

Treatment Naive (Cohort 2)

ACTIVE COMPARATOR

Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.

Drug: ranibizumab

Interventions

ranibizumab DRUG

Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.

Also known as: Lucentis

Treatment Experienced (Cohort 1; Treatment Naive (Cohort 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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
• For patients previously treated with ITV ranibizumab (Cohort 1):
• or more intravitreal injections of ranibizumab with presence of persistent edema after a minimum of 6 ranibizumab injections followed in RAVE 1.
• For treatment naïve (Cohort 2):
• Three of the following clinical tests must be present to demonstrate ischemic CRVO:
• VA 20/200 or worse
• RAPD 0.9 LU or worse
• Loss of 1-2e isopter on Goldmann Visual field (Kwon et al. 2001)
• ERG demonstrating b wave amplitude less than 60% of A wave
• Capillary nonperfusion greater than 50 DA

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from this study:
• IOP over 30 mm Hg
• Any previous retinal laser photocoagulation to the study eye in treatment naive
• Any previous intravitreal injection in study eye (triamcinolone or other) in treatment naive
• Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery)
• Intracapsular cataract extraction (posterior capsule needs to be present)
• Previous history of retinal detachment in study eye
• Any previous radiation treatments to head/ neck
• Inability to assess iris neovascularization (corneal opacity precluding gonioscopy)
• Significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12 month study
• Significant diabetic retinopathy in the fellow eye (diabetic macular edema, proliferative diabetic retinopathy, or high-risk non-proliferative diabetic retinopathy)
• Pregnancy (positive pregnancy test)
• Participation in another simultaneous medical investigator or trial
• Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., DME AMD, ocular histoplasmosis, or pathologic myopia)
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period

Sponsors & Collaborators

• David M. Brown, M.D.: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Wykoff CC, Brown DM, Croft DE, Major JC Jr, Wong TP. Progressive retinal nonperfusion in ischemic central retinal vein occlusion. Retina. 2015 Jan;35(1):43-7. doi: 10.1097/IAE.0000000000000277.

  PMID: 25102193 DERIVED

MeSH Terms

Conditions

Ischemia; Retinal Vein Occlusion; Pathologic Processes; Retinal Diseases; Eye Diseases; Bites and Stings

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: David M. Brown, MD
• Organization: Retina Consultants of Houston

dmbmd@houstonretina.com

713-524-3434

Study Officials

• Charles C Wykoff, MD, PhD

  Retina Consultants Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 20, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 14, 2017
• Results First Posted: August 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)