Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions (RELATE)

February 16, 2016 updated by: Peter A Campochiaro, MD

RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach(RELATE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute at Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ranibizumab 0.5mg (monthly)
Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
Experimental: 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.
Drug: Pro re nata (prn) ranibizumab
Procedure: Pro re nata (prn) Laser photocoagulation
Experimental: 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.
Drug: Ranibizumab 2.0mg (monthly)
Experimental: 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.
Drug: Pro re nata (prn) ranibizumab
Experimental: 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
Drug: Ranibizumab 0.5mg (monthly)
Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
Experimental: 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.
Drug: Pro re nata (prn) ranibizumab
Procedure: Pro re nata (prn) Laser photocoagulation
Experimental: 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.
Drug: Ranibizumab 2.0mg (monthly)
Experimental: 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.
Drug: Pro re nata (prn) ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and Severity of Ocular and Non-ocular Adverse Events.
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab
Time Frame: Baseline to month 6
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.
Time Frame: Month 6- Month 36
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
Time Frame: Baseline to month 6
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.
Time Frame: Month 6- Month 36
Month 6- Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter A Campochiaro, MD

Collaborators

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00032394

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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