Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.

NCT01449682 | Completed Phase 3 Results

• 1 other identifier: IIT-287
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.

Conditions

Retinal Vein Occlusion; Macular Edema

Keywords

BRVO; CRVO; Macular Edema; Anti-VEGF; Ozurdex

Outcome Measures

Primary Outcomes (2)

• Macular Function Using Microperimetry

  To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups

  baseline to 48 weeks

• Macular Function Using Multi-focal ERG

  To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups

  baseline to 48 weeks

Secondary Outcomes (2)

• To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups

  baseline to 48 weeks

• To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups

  baseline to 48 weeks

Study Arms (2)

Ozurdex PRN

ACTIVE COMPARATOR

0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT

Drug: Ozurdex

Ozurdex Q16 weeks

ACTIVE COMPARATOR

0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks

Drug: Ozurdex

Interventions

Ozurdex DRUG

0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies

Also known as: Dexamethasone implant, DEX implant

Ozurdex PRN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)
• Prior treatment with \>= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.
• Age 18 years or older
• ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800
• Central foveal thickness \>275 microns or presence of cystic edema on OCT studies.
• For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.
• Ability to provide written informed consent • Capable of complying with study protocol

You may not qualify if:

• History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.
• Intraocular injection of steroid medication within prior 4 months
• Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.
• Previous laser photocoagulation within 4 months of study
• Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician
• Patients who are pregnant.
• Unwilling or unable to follow or comply with all study related procedures.

Sponsors & Collaborators

• Retina Macula Institute: lead
• Allergan: collaborator

Study Sites (1)

Retina Macula Institute

Torrance, California, 90503, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Ron P. Gallemore, M.D., Ph. D.
• Organization: Retina Macula Institute

rongallemoremd@gmail.com

310) 944-9393

Study Officials

• Ron P Gallemore, M.D. Ph.D

  Retina Macula Institute

  PRINCIPAL INVESTIGATOR

• Behnam Sharareh, B.S

  Retina Macula Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 10, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 31, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-04

Locations

US (1)