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

• Status: Completed
• Trial end date: 2021-09-15
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Dexamethasone; Ranibizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• ● 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.