Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME

Sponsor
Beijing Hospital
Study ID
NCT03690947
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Intravitreal Ranibizumab — DRUG
    All subjections received 3 initial Ranibizumab injections
  • Micropulse Laser — PROCEDURE
    After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
  • Intravitreal Ranibizumab as needed — DRUG
    After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization

Study Details

The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.

Key Dates

First listed
Oct 1, 2018
Start date
Oct 1, 2018
Status verified
Dec 2022
Primary completion
Aug 31, 2021
Completion
Sep 30, 2021

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy Group
  • Active Comparator: Intravitreal Ranibizumab Group

Primary Outcome Measure

Best Corrected Visual Acuity changes [ Time Frame: 12 months ]

Related Studies