Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

Retinal Vein Occlusions Clinical Trial

Official title:

A 6-Month, Single Site, Masked, Randomized,Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085734
• Other study ID #: OA001
• Status: Completed
• Phase: Phase 4
• First received: March 10, 2010
• Last updated: March 13, 2014
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2014
• Source: Maturi, Raj K., M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male or female age 18 years or older

• Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration

• Best correct visual acuity of greater than 24 and less than 80

• Presence of macular edema defined as OCT central subfield thickness of >250

Exclusion Criteria:

• intravitreal anti-VEGF treatment in study eye within six weeks of baseline

• intravitreal steroid treatment in the study eye within eight weeks of baseline visit

• PRP in the study eye within 4 month of baseline visit

• Active iris neovascularization in study eye

• Uncontrolled systemic disease

• Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion
• Retinal Vein Occlusions

Intervention

Drug:
• Avastin
1.25mg intravitreally
• Osurdex
0.7mg intravitreally
• Avastin
1.25mg intravitreally

Locations

Country	Name	City	State
United States	Raj K. Maturi, MD	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Maturi, Raj K., M.D., P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Visual Acuity at 6 Months	Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.	6 months	No
Secondary	Number of Injections Needed	number of Avastin and Ozurdex injections needed	baseline to 6 months	No
Secondary	Change in Macular Thickness and Macular Volume	OCT central subfield thickness measured in microns	6 months	No