Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)

NCT01231633 | Completed Results

• 1 other identifier: IST CRVO 1118147
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).

Conditions

Macular Edema; Central Retinal Vein Occlusion

Keywords

Macular Edema; Central Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (2)

• The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm

  The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm

  Baseline - Month 6

• The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm

  Total Number of addiitonal Avastin injections during study- From baseline to Month 6

  Baseline - Month 6

Secondary Outcomes (1)

• Change in Central Mean Thickness Based on OCT

  Baseline to 6 Months

Study Arms (2)

Group 1

EXPERIMENTAL

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Drug: Ozurdex; Drug: Avastin

Group 2

ACTIVE COMPARATOR

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Drug: Avastin

Interventions

Ozurdex DRUG

Ozurdex, 0.7mg dexamethasone

Also known as: Dexamethasone implant

Group 1

Avastin DRUG

Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Also known as: Avastin, bevacizumab

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of central retinal vein occlusion (CRVO)
• Age 18 years or older
• ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800
• OCT Central foveal thickness \>250 microns
• Negative pregnancy test for women of childbearing potential
• Ability to provide written informed consent
• Capable of complying with study protocol

You may not qualify if:

• History of glaucoma in the study eye with intraocular pressure \>21mmHg on more than one topical medication. Combination drugs are considered more than one medication
• History of steroid-related glaucoma (steroid response)
• Previous intraocular injection of steroid medication within 90 days
• Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days
• Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician
• Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days
• Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician
• Dense cataract that precludes clinical examination and retinal imaging of the retina
• History of allergy to dexamethasone, bevacizumab, betadine
• Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician
• Unwilling or unable to follow or comply with all study related procedures
• Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment

Sponsors & Collaborators

• Long Island Vitreoretinal Consultants: lead

Study Sites (4)

Retina Vitreous Center

Toms River, New Jersey, 08755, United States

Location

Long Island Vitreoretinal Consultants

Great Neck, New York, 11021, United States

Location

Long Island Vitreoretinal Consultants

Hauppauge, New York, 11788, United States

Location

Long Island Vitreoretinal Consultants

Riverhead, New York, 11901, United States

Location

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

Calcium Dobesilate; Dexamethasone; Bevacizumab

Condition Hierarchy (Ancestors)

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

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; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Vincent A. Deramo, MD
• Organization: Long Island Vitreoretinal Consultants

vaderamo@gmail.com

5164660390

Study Officials

• Vincent A Deramo, M.D

  Long Island Vitreoretinal Consultants

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 3, 2018
• Results First Posted: April 3, 2018

Record last verified: 2018-03

Locations

US (4)