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

Maturi, Raj K., M.D., P.C.

Status and phase: Completed; Phase 4

Conditions: Diabetic Macular Edema

Treatments: Drug: dexamethasone intravitreal implant; Drug: Bevacizumab

Study type: Interventional

Identifiers

NCT01309451

OA002

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Bevacizumab alone

Active Comparator group

Treatment:

Drug: Bevacizumab

Combined group

Active Comparator group

Description:

Bevacizumab plus Ozurdex

Treatment:

Drug: Bevacizumab

Drug: dexamethasone intravitreal implant