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The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema

Primary Purpose

Refractory Diabetic Macular Edema

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
injection of bevacizumab and erythropoietin
injection of bevacizumab
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Diabetic Macular Edema

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

intravitreal injection of bevacizumab and erythropoietin

intravitreal injection of bevacizumab

Arm Description

erythropoietin:

bevacizumab:1.25 mg

Outcomes

Primary Outcome Measures

best corrected visual acuity
Snellen chart

Secondary Outcome Measures

Optical coherence tomography
Optical coherence tomography

Full Information

First Posted
December 27, 2018
Last Updated
February 2, 2019
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03821168
Brief Title
The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema
Official Title
The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravitreal injection of bevacizumab and erythropoietin
Arm Type
Active Comparator
Arm Description
erythropoietin:
Arm Title
intravitreal injection of bevacizumab
Arm Type
Active Comparator
Arm Description
bevacizumab:1.25 mg
Intervention Type
Drug
Intervention Name(s)
injection of bevacizumab and erythropoietin
Intervention Description
injection of bevacizumab and erythropoietin
Intervention Type
Drug
Intervention Name(s)
injection of bevacizumab
Intervention Description
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness
Primary Outcome Measure Information:
Title
best corrected visual acuity
Description
Snellen chart
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Optical coherence tomography
Description
Optical coherence tomography
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morteza Entezari, MD
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morteza Entzari, MD
Phone
009822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31401683
Citation
Entezari M, Flavarjani ZK, Ramezani A, Nikkhah H, Karimi S, Moghadam HF, Daftarian N, Yaseri M. Combination of intravitreal bevacizumab and erythropoietin versus intravitreal bevacizumab alone for refractory diabetic macular edema: a randomized double-blind clinical trial. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2375-2380. doi: 10.1007/s00417-019-04383-2. Epub 2019 Aug 10.
Results Reference
derived

Learn more about this trial

The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema

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