The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema
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ClinicalTrials.gov Identifier: NCT03821168 |
Recruitment Status : Unknown
Verified December 2018 by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : January 29, 2019
Last Update Posted : February 5, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Refractory Diabetic Macular Edema | Drug: injection of bevacizumab and erythropoietin Drug: injection of bevacizumab | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 58 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema |
Estimated Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | April 1, 2019 |
Estimated Study Completion Date : | October 1, 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: intravitreal injection of bevacizumab and erythropoietin
erythropoietin:
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Drug: injection of bevacizumab and erythropoietin
injection of bevacizumab and erythropoietin |
Active Comparator: intravitreal injection of bevacizumab
bevacizumab:1.25 mg
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Drug: injection of bevacizumab
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness |
- best corrected visual acuity [ Time Frame: 1 month ]Snellen chart
- Optical coherence tomography [ Time Frame: 1 month ]Optical coherence tomography

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821168
Contact: Morteza Entezari, MD | 009822591616 | labbafi@hotmail.com |
Iran, Islamic Republic of | |
Ophthalmic Research Center | Recruiting |
Tehran, Iran, Islamic Republic of | |
Contact: Morteza Entzari, MD 009822591616 labbafi@hotmail.com |
Responsible Party: | Zahra Rabbani Khah, Clinical Professor, Shahid Beheshti University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT03821168 |
Other Study ID Numbers: |
95287 |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | February 5, 2019 |
Last Verified: | December 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Macular Edema Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Bevacizumab Epoetin Alfa |
Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Hematinics |