The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedFebruary 5, 2019
December 1, 2018
1 month
December 27, 2018
February 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
best corrected visual acuity
Snellen chart
1 month
Secondary Outcomes (1)
Optical coherence tomography
1 month
Study Arms (2)
intravitreal injection of bevacizumab and erythropoietin
ACTIVE COMPARATORerythropoietin:
intravitreal injection of bevacizumab
ACTIVE COMPARATORbevacizumab:1.25 mg
Interventions
injection of bevacizumab and erythropoietin
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness
Eligibility Criteria
You may qualify if:
- Patient with refractory diabetic macular edema at least one month after third injection
You may not qualify if:
- previous vitreoretinal surgery previous glaucoma surgery glaucomatous patient open heart surgery active proliferative diabetic retinopathy one eye patients vitreous hemorrhage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Research Center
Tehran, Iran
Related Publications (1)
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.
PMID: 31401683DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
December 27, 2018
First Posted
January 29, 2019
Study Start
March 1, 2019
Primary Completion
April 1, 2019
Study Completion
October 1, 2019
Last Updated
February 5, 2019
Record last verified: 2018-12