Anti-VEGF Therapy Versus Dexamethasone Implant for DME

Conditions

• Clinically Significant Macular Edema Due to Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Aflibercept, — DRUG
  Primary therapy will be with Aflibercept. If the edema does not respond to the intervention, the patient will be treated with Ranibizumab, Dexamethasone Implant or Laser.
• Ranibizumab Injection — DRUG
  Primary therapy will be with ranibizumab. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Dexamethasone Implant or Laser.
• Ozurdex Drug Implant Product — DRUG
  Primary therapy will be with Ozurdex. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Ranibizumab or Laser

Study Details

We look at a randomized comparative study of 2 FDA approved anti-VEGF agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years.

Key Dates

Start date

Jun 25, 2019

Status verified

Jun 2019

Primary completion

Jun 24, 2021

Completion

Jun 24, 2023

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Group 1
  Aflibercept intravitreal injection for CSME
• Other: Group 2
  Ranibizumab Intravitreal Injection for CSME
• Experimental: Group 3
  Dexamethasone Implant for CSME

Primary Outcome Measure

Best Corrected Visual Acuity [ Time Frame: 2 years ]