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

Macular Edema Clinical Trial

Official title:

Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231633
• Other study ID #: IST CRVO 1118147
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: March 5, 2018
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: March 2018
• Source: Long Island Vitreoretinal Consultants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ozurdex
Ozurdex, 0.7mg dexamethasone
• Avastin
Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Locations

Country	Name	City	State
United States	Long Island Vitreoretinal Consultants	Great Neck	New York
United States	Long Island Vitreoretinal Consultants	Hauppauge	New York
United States	Long Island Vitreoretinal Consultants	Riverhead	New York
United States	Retina Vitreous Center	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Long Island Vitreoretinal Consultants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Central Mean Thickness Based on OCT	Change in Central Mean Thickness based on OCT from baseline to Month 6t	Baseline to 6 Months