Diabetic Macular Edema (DME) Treatment With Ranibizumab and Dexamethasone or Ranibizumab Only.

Sponsor
He Eye Hospital
Study ID
NCT04601675
Status
Unknown

Conditions

  • Macular Edema

Eligibility Criteria

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

Interventions

  • Ranibizumab Ophthalmic and Intravitreal Dexamethasone — DRUG
    Pro re nata patients with macula edema due to diabetes will receive Ranibizumab. Group A will continue to receive Ranibizumab depending on their clinical status of macular edema
  • Ranibizumab Ophthalmic only — DRUG
    Group B will initially receive intravitreal Dexamethasone and Ranibizumab and then depending on their clinical status of macular edema, Ranibizumab will be injected.

Study Details

The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Ranibizumab or combination of Ranibizumab And Dexamethasone under pro re nata treatment regimen for Diabetic Macular Edema patients.

Key Dates

First listed
Oct 26, 2020
Start date
Oct 31, 2020
Status verified
Jun 2020
Primary completion
Mar 1, 2021
Completion
Sep 17, 2021

Study Design

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

Arms

  • Experimental: Diabetic ME: Ranibizumab and intravitreal Dexamethasone
    Participants with diabetic macular edema will receive a combination of Ranibizumab and intravitreal Dexamethasone
  • Active Comparator: Diabetic ME: Ranibizumab
    Participants with diabetic macular edema (ME) will receive Ranibizumab only.

Primary Outcome Measure

Mean change in monocular BCVA in the treatment eye [ Time Frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months. ]

Central Contacts

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