Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
RELATE
RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach(RELATE)
1 other identifier
interventional
81
1 country
1
Brief Summary
The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal vein occlusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
March 15, 2016
CompletedMarch 15, 2016
February 1, 2016
5.4 years
October 26, 2009
August 25, 2015
February 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and Severity of Ocular and Non-ocular Adverse Events.
36 months
Secondary Outcomes (4)
Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab
Baseline to month 6
Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.
Month 6- Month 36
Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab
Baseline to month 6
Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.
Month 6- Month 36
Study Arms (8)
BRVO- Ranibizumab 0.5mg alone
EXPERIMENTALBranch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.
BRVO- Pro re nata (prn) ranibizumab with laser
EXPERIMENTALBranch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
BRVO- Ranibizumab 2.0mg alone
EXPERIMENTALBranch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
BRVO- Pro re nata (prn) ranibizumab
EXPERIMENTALBranch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
CRVO- Ranibizumab 0.5mg alone
EXPERIMENTALCentral retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
CRVO- Pro re nata (prn) ranibizumab with laser
EXPERIMENTALCentral retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
CRVO- Ranibizumab 2.0mg alone
EXPERIMENTALCentral retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
CRVO- Pro re nata (prn) ranibizumab
EXPERIMENTALCentral retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
Interventions
Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
Eligibility Criteria
You may qualify if:
- Signed informed consent and authorization of use and disclosure of protected health information
- Age equal to or greater than 18 years
- Diagnosis of macular edema due to central or branch retinal vein occlusion
- Foveal thickness of equal to or greater than 250 mm, as assessed by OCT
- Best corrected visual acuity score in the study eye of 20/40 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled.
- In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision
You may not qualify if:
- Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
- Intraocular surgery in the study eye within 3 months of study entry
- Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry
- Previous use of an anti-VEGF drug within 3 months of study entry
- Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0.
- History of vitreoretinal surgery in the study eye within 3 months of study entry
- Uncontrolled glaucoma (defined as intraocular pressure ³30 mm Hg despite treatment with anti-glaucoma medications)
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- 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.
- Have the presence of active malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled.
- Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
- History of allergy to humanized antibodies or any component of the ranibizumab formulation
- Inability to comply with study or followup procedures
- Participation in another simultaneous medical investigation or trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peter A Campochiaro, MDlead
- Genentech, Inc.collaborator
Study Sites (1)
Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter A. Campochiaro, MD
- Organization
- Wilmer Eye Institute, Johns Hopkins University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Peter A Campochiaro, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 26, 2009
First Posted
October 28, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
March 15, 2016
Results First Posted
March 15, 2016
Record last verified: 2016-02