The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema

Refractory Diabetic Macular Edema Clinical Trial

Official title:

The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821168
• Other study ID #: 95287
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: December 2018
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Morteza Entezari, MD
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

after advent of RD photoreceptor degeneration Occurred. This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened .

Process of degeneration begins from first hours of RD establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years .

How to stop this phenomena and neuroprotective agent role in this issue are a new interest of researches.

In the study investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: October 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient with refractory diabetic macular edema at least one month after third injection

Exclusion Criteria:

• previous vitreoretinal surgery previous glaucoma surgery glaucomatous patient open heart surgery active proliferative diabetic retinopathy one eye patients vitreous hemorrhage

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Refractory Diabetic Macular Edema

Intervention

Drug:
• injection of bevacizumab and erythropoietin
injection of bevacizumab and erythropoietin
• injection of bevacizumab
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best corrected visual acuity	Snellen chart	1 month
Secondary	Optical coherence tomography	Optical coherence tomography	1 month