- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03821168
The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Morteza Entezari, MD
- Phone Number: 009822591616
- Email: labbafi@hotmail.com
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- Ophthalmic Research Center
-
Contact:
- Morteza Entzari, MD
- Phone Number: 009822591616
- Email: labbafi@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: intravitreal injection of bevacizumab and erythropoietin
erythropoietin:
|
injection of bevacizumab and erythropoietin
|
ACTIVE_COMPARATOR: intravitreal injection of bevacizumab
bevacizumab:1.25 mg
|
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
best corrected visual acuity
Time Frame: 1 month
|
Snellen chart
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optical coherence tomography
Time Frame: 1 month
|
Optical coherence tomography
|
1 month
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Hematinics
- Bevacizumab
- Epoetin Alfa
Other Study ID Numbers
- 95287
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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