RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach(RELATE)
Overview
- Phase
- Phase 1
- Intervention
- Ranibizumab 0.5mg (monthly)
- Conditions
- Retinal Vein Occlusion
- Sponsor
- Peter A Campochiaro, MD
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Incidence and Severity of Ocular and Non-ocular Adverse Events.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Detailed Description
The secondary objectives are to assess the efficacy of 0.5mg versus 2.0mg of monthly ranibizumab injections in patients with macular edema due to retinal vein occlusion between baseline and month 6. At week 24, patients will be re-randomized to receive pro re nata (prn) ranibizumab+laser photocoagulation versus ranibizumab alone and the efficacy of both treatment options will be compared. Treatment efficacy will be assessed by comparing changes in best corrected visual acuity (BCVA) and central subfiled thickness (CST) between the treatment groups.
Investigators
Peter A Campochiaro, MD
Principal Investigator
Johns Hopkins University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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.
Arms & Interventions
BRVO- Ranibizumab 0.5mg alone
Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.
Intervention: Ranibizumab 0.5mg (monthly)
BRVO- Pro re nata (prn) ranibizumab with laser
Branch 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.
Intervention: Pro re nata (prn) ranibizumab
BRVO- Pro re nata (prn) ranibizumab with laser
Branch 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.
Intervention: Pro re nata (prn) Laser photocoagulation
BRVO- Ranibizumab 2.0mg alone
Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
Intervention: Ranibizumab 2.0mg (monthly)
BRVO- Pro re nata (prn) ranibizumab
Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
Intervention: Pro re nata (prn) ranibizumab
CRVO- Ranibizumab 0.5mg alone
Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
Intervention: Ranibizumab 0.5mg (monthly)
CRVO- Pro re nata (prn) ranibizumab with laser
Central 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.
Intervention: Pro re nata (prn) ranibizumab
CRVO- Pro re nata (prn) ranibizumab with laser
Central 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.
Intervention: Pro re nata (prn) Laser photocoagulation
CRVO- Ranibizumab 2.0mg alone
Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
Intervention: Ranibizumab 2.0mg (monthly)
CRVO- Pro re nata (prn) ranibizumab
Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
Intervention: Pro re nata (prn) ranibizumab
Outcomes
Primary Outcomes
Incidence and Severity of Ocular and Non-ocular Adverse Events.
Time Frame: 36 months
Secondary Outcomes
- 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)