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

NCT ID: NCT01003106

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2015-04-30

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.

Conditions

Retinal Vein Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ranibizumab 0.5mg (monthly)

Intervention Type: DRUG

Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone

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.

Group Type: EXPERIMENTAL

Pro re nata (prn) ranibizumab

Intervention Type: DRUG

Pro re nata (prn) Laser photocoagulation

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Ranibizumab 2.0mg (monthly)

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Pro re nata (prn) ranibizumab

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Ranibizumab 0.5mg (monthly)

Intervention Type: DRUG

Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone

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.

Group Type: EXPERIMENTAL

Pro re nata (prn) ranibizumab

Intervention Type: DRUG

Pro re nata (prn) Laser photocoagulation

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Ranibizumab 2.0mg (monthly)

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Pro re nata (prn) ranibizumab

Intervention Type: DRUG

Interventions

Ranibizumab 0.5mg (monthly)

Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone

Intervention Type: DRUG

Ranibizumab 2.0mg (monthly)

Intervention Type: DRUG

Pro re nata (prn) ranibizumab

Intervention Type: DRUG

Pro re nata (prn) Laser photocoagulation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Peter A Campochiaro, MD

OTHER

Sponsor Role: lead

Responsible Party

Peter A Campochiaro, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter A Campochiaro, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00032394

Identifier Type: -

Identifier Source: org_study_id