The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema

NCT ID: NCT03821168

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Refractory Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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intravitreal injection of bevacizumab and erythropoietin

erythropoietin:

Group Type ACTIVE_COMPARATOR

injection of bevacizumab and erythropoietin

Intervention Type DRUG

injection of bevacizumab and erythropoietin

intravitreal injection of bevacizumab

bevacizumab:1.25 mg

Group Type ACTIVE_COMPARATOR

injection of bevacizumab

Intervention Type DRUG

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

Interventions

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injection of bevacizumab and erythropoietin

injection of bevacizumab and erythropoietin

Intervention Type DRUG

injection of bevacizumab

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmic Research Center

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Morteza Entezari, MD

Role: CONTACT

009822591616

Facility Contacts

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Morteza Entzari, MD

Role: primary

009822591616

References

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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.

Reference Type DERIVED
PMID: 31401683 (View on PubMed)

Other Identifiers

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95287

Identifier Type: -

Identifier Source: org_study_id

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