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Search / Trial NCT05271539

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

Launched by CAIRO UNIVERSITY · Feb 27, 2022

Trial Information

Current as of July 07, 2025

Completed

Keywords

ClinConnect Summary

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 In...

Gender

ALL

Eligibility 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.

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

Giza, Cairo, Egypt

Patients applied

0 patients applied

Trial Officials

Khaled G Abueleinen, MD, PhD

Principal Investigator

Ophthalmology department, Faculty of Medicine Cairo University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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