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

Retinal Vein Occlusion Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003106
• Other study ID #: NA_00032394
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 26, 2009
• Last updated: February 16, 2016
• Start date: November 2009
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab 0.5mg (monthly)
Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
• Ranibizumab 2.0mg (monthly)

• Pro re nata (prn) ranibizumab

Procedure:
• Pro re nata (prn) Laser photocoagulation

Locations

Country	Name	City	State
United States	Wilmer Eye Institute at Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Peter A Campochiaro, MD	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of Ocular and Non-ocular Adverse Events.		36 months	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No