Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.

Sponsor
Cairo University
Study ID
NCT03458923
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diclofenac Sodium 0.1 ml containing 500µg — DRUG
    15 eyes will receive intravitreal 0.1 ml containing 500µg of Diclofenac Sodium monthly for three months
  • Ranibizumab 0.5 mg Solution for Injection — DRUG
    15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months

Study Details

The study aims to compare the effect of intravitreal non steroidal anti inflammatory (Diclofenac) versus the standard treatment of diabetic macular edema, intravitreal anti vascular endothelial growth factor (Ranibizumab), measuring central macular thickness changes and best corrected visual acuity.

Key Dates

First listed
Mar 8, 2018
Start date
Jan 31, 2015
Status verified
Mar 2018
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A
    15 eyes will receive 0.1 ml containing 500µg of diclofenac intravitreally, repeated monthly for 3 months.
  • Active Comparator: Group B
    15 eyes will receive 0.5 mg Ranibizumab intravitreally, repeated monthly for 3 months.

Primary Outcome Measure

Change in best corrected visual acuity [ Time Frame: 3 months of follow up ]

Central Contacts

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