A Phase 3 interventional study of Lucentis alone group and Lucentis dexamethasone group in Diabetic Macular Edema, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-09.
Sponsored by Cairo University · Phase 3, Interventional, and Treatment
Intravitreal ranibizumab alone was Compared to adding dexamethasone to ranibizumab regarding central macular thickness, the visual acuity and the number of intravitreal injections needed to achieve the same effect on CMT and BCVA at the end of the 6 months duration of the study. Any significant change in final IOP, compared to baseline, in either group is reported.
This prospective randomized study measures the changes in central macular thickness, best corrected visual acuity and IOP in diabetic macular edema before and after the intravitreal injection of ranibizumab and dexamethasone, compared to ranibizumab alone, the current gold standard of care for diabetic macular edema.
Study participants were randomized into 2 groups: the first group received 3 Intravitreal injections of ranibizumab alone 1 month apart. While the second group received 1 Intravitreal injection of a combination of ranibizumab and 0.4 mg in 0.1 ml dexamethasone followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline). Treatment was stopped when the treated eye achieved a central macular thickness of 250 microns or less with no focal parafoveal edema.
Final recorded central macular thickness in both groups compared to the baseline. By the end of the follow up period.
Final visual acuity was assessed in both groups compared to the baseline Change in final IOP, compared to baseline, in ranibizumab group and ranibizumab with dexamethasone group.
. The number of injections needed to achieve the same effect on CMT and BCVA.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 42 is below the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
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Exclusion Criteria:
● History of any treatment for DME (including grid or focal laser photocoagulation) within the last 6 months
The first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle.
Drug: Lucentis alone group
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).
Drug: Lucentis dexamethasone 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
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.
Central foveal thickness
Central foveal thickness in microns measured by OCT
Time frame: 6 months after the first injection
BCVA (Decimal)
Best corrected visual acuity measured on Snellen chart in Decimal form
Time frame: 6 months after the first injection
The number of injections
The total number of injections in each Arm group
Time frame: over 6 months duration of the study
IOP
Intraocular pressure
Time frame: 6 months after the first injection
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Cairo University