Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema

PHASE3CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

July 1, 2021

Study Completion Date

September 15, 2021

Conditions
Diabetic Macular Edema
Interventions
DRUG

Lucentis alone group

The Lucentis alone group received 3 monthly intravitreal injections of lucentis alone or less than 3 injections if the central foveal thickness reached 250 microns

DRUG

Lucentis dexamethasone group

Lucentis dexamethasone group received intravitreal injections of combination of both lucentis and commercial dexamethasone. the second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN). Treatment was stopped when CMT improved below 250 µ.

Trial Locations (1)

12411

Khaled G Abueleinen, Giza

All Listed Sponsors
lead

Cairo University

OTHER

NCT05271539 - Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema | Biotech Hunter | Biotech Hunter