Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309451
• Other study ID #: OA002
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2011
• Last updated: October 28, 2014
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2014
• Source: Maturi, Raj K., M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female age 18 years or older

• Type 1 or type 2 diabetes

• BCVA score of >24 and <78 letters

• Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) >250microns

Exclusion Criteria:

• Anti-VEGF intravitreal treatment in last 4 weeks

• Intravitreal steroid treatment in the last 8 weeks

• PRP or Focal laser in last 4 months

• Active iris neovascularization

Study Design

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Bevacizumab
intravitreal, 1.25mg., monthly
• dexamethasone intravitreal implant
0.7mg, intravitreal every 4 months

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 in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline	Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.	baseline to 12 month	No
Primary	OCT CST	change in optical coherence tomography central subfield thickness	change in OCT CST from baseline to twelve months	No