Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy

NCT ID: NCT04469777

Last Updated: 2021-04-01

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-12-30

Brief Summary

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This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy.

Detailed Description

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Injury of the optic nerve or optic neuropathy is one of the most common causes of vision loss. This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy.

Conditions

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Optic Neuropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study included 20 patients diagnosed as late onset optic neuropathy that are attending Alexandria main university hospital.

All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Systemic erythropoietin injections

20 patients diagnosed as late onset optic neuropathy that were attending Alexandria main university hospital.Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).

Group Type EXPERIMENTAL

erythropoietin

Intervention Type DRUG

Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).

Interventions

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erythropoietin

Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with late stage optic neuropathy (1 month to 12 months after onset of optic neuropathy due to late referral of the cases)

Exclusion Criteria

* Patients with perforating ocular injuries were excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Fahmy Doheim

Prinicipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mai ElBahwash, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria Faculty of Medicine

Locations

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Alexandria Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0304649

Identifier Type: -

Identifier Source: org_study_id

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