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The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Refractory Diabetic Macular Edema Drug: injection of bevacizumab and erythropoietin Drug: injection of bevacizumab Phase 2 Phase 3

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: intravitreal injection of bevacizumab and erythropoietin
erythropoietin:
Drug: injection of bevacizumab and erythropoietin
injection of bevacizumab and erythropoietin

Active Comparator: intravitreal injection of bevacizumab
bevacizumab:1.25 mg
Drug: injection of bevacizumab
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness




Primary Outcome Measures :
  1. best corrected visual acuity [ Time Frame: 1 month ]
    Snellen chart


Secondary Outcome Measures :
  1. Optical coherence tomography [ Time Frame: 1 month ]
    Optical coherence tomography



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Information from the National Library of Medicine

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


Contacts
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Contact: Morteza Entezari, MD 009822591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Morteza Entzari, MD    009822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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