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

Primary Purpose

Retinal Vein Occlusion

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab 0.5mg (monthly)
Ranibizumab 2.0mg (monthly)
Pro re nata (prn) ranibizumab
Pro re nata (prn) Laser photocoagulation
Sponsored by
Peter A Campochiaro, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring RVO, BRVO, CRVO, Vein occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wilmer Eye Institute at Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

BRVO- Ranibizumab 0.5mg alone

BRVO- Pro re nata (prn) ranibizumab with laser

BRVO- Ranibizumab 2.0mg alone

BRVO- Pro re nata (prn) ranibizumab

CRVO- Ranibizumab 0.5mg alone

CRVO- Pro re nata (prn) ranibizumab with laser

CRVO- Ranibizumab 2.0mg alone

CRVO- Pro re nata (prn) ranibizumab

Arm Description

Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.

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.

Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.

Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.

Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation

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.

Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.

Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.

Outcomes

Primary Outcome Measures

Incidence and Severity of Ocular and Non-ocular Adverse Events.

Secondary Outcome Measures

Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab
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.
Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab
Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.

Full Information

First Posted
October 26, 2009
Last Updated
February 16, 2016
Sponsor
Peter A Campochiaro, MD
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01003106
Brief Title
Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
Acronym
RELATE
Official Title
RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach(RELATE)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter A Campochiaro, MD
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
RVO, BRVO, CRVO, Vein occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRVO- Ranibizumab 0.5mg alone
Arm Type
Experimental
Arm Description
Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.
Arm Title
BRVO- Pro re nata (prn) ranibizumab with laser
Arm Type
Experimental
Arm Description
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.
Arm Title
BRVO- Ranibizumab 2.0mg alone
Arm Type
Experimental
Arm Description
Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
Arm Title
BRVO- Pro re nata (prn) ranibizumab
Arm Type
Experimental
Arm Description
Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
Arm Title
CRVO- Ranibizumab 0.5mg alone
Arm Type
Experimental
Arm Description
Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
Arm Title
CRVO- Pro re nata (prn) ranibizumab with laser
Arm Type
Experimental
Arm Description
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.
Arm Title
CRVO- Ranibizumab 2.0mg alone
Arm Type
Experimental
Arm Description
Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
Arm Title
CRVO- Pro re nata (prn) ranibizumab
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ranibizumab 0.5mg (monthly)
Intervention Description
Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 2.0mg (monthly)
Intervention Type
Drug
Intervention Name(s)
Pro re nata (prn) ranibizumab
Intervention Type
Procedure
Intervention Name(s)
Pro re nata (prn) Laser photocoagulation
Primary Outcome Measure Information:
Title
Incidence and Severity of Ocular and Non-ocular Adverse Events.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Campochiaro, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilmer Eye Institute at Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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

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