Status:
COMPLETED
Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema
Lead Sponsor:
Cairo University
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
15-80 years
Phase:
PHASE3
Brief Summary
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 th...
Detailed Description
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 ranib...
Eligibility Criteria
Inclusion
- Diabetic macular edema with central macular thickness of 300 μm or greater (as measured by spectral domain optical coherence tomography \[OCT\]).
- Best corrected visual acuity of 6/12 or less.
Exclusion
- ● History of any treatment for DME (including grid or focal laser photocoagulation) within the last 6 months
- History of panretinal photocoagulation within the last 6 months.
- PDR as indicated with Fluorescein Angiography as it will require PRP which may affect DME.
- Macular ischemia, as indicated with Fluorescein Angiography.
- Cataract surgery within three months or cataract that requires surgical intervention during the follow-up period.
- Pseudophakia with Irvine Gass syndrome, as indicated with Fluorescein Angiography.
- Vitreomacular traction syndrome.
- Other causes of macular edema (eg. CRVO, CNV, uveitis, etc).
- Glaucoma, whether suspected or confirmed.
- Significant media opacity.
- Patients with ocular or periocular infections, or infection in the other eye
- Signs of Active or resolved uveitis and intraocular inflammation.
- Bad diabetic control as indicated by HbA1C \>8.
- Renal impairment, hepatic impairment, or congestive heart failure.
- History of cardiovascular insult or stroke.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05271539
Start Date
July 1 2020
End Date
September 15 2021
Last Update
March 9 2022
Active Locations (1)
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1
Khaled G Abueleinen
Giza, Cairo Governorate, Egypt, 12411