Treatment for Optic Nerve Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fakeeh University Hospital, Dubai, United Arab Emirates
Optic Nerve Diseases+23 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Stem Cell Ophthalmology Treatment Study II

See full description

Eligible Conditions

  • Optic Nerve Diseases
  • Retinal Disorders
  • Macula Abnormality
  • Vision Loss Partial
  • Optic Neuropathies
  • Retinal Diseases
  • Age - Related Macular Degeneration (AMD)
  • Retinitis Pigmentosa
  • Amaurosis
  • Vision Loss Night
  • Glaucoma
  • Leber Hereditary Optic Neuropathy (Optic, Atrophy, Hereditary, Leber)
  • Non Arteritic Ischemic Optic Neuropathy
  • Optic Atrophy
  • Vision, Low
  • Stargardt Disease
  • Macular Degeneration
  • Retina Atrophy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Optic Nerve Diseases. Measurement will happen over the course of Change from pre-procedure to 12 months.

Month 12
Optical Coherence Tomography (OCT)
Visual Acuity
Visual Fields

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm 2
1 of 2
Arm 3
1 of 2
Active Control

This trial requires 500 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arm 2
Procedure
BMSC provided retrobulbar, subtenon, intravitreal and intravenous for one or both eyes
Arm 3BMSC provided either intraoptic nerve or subretinal for eye with worse vision with fellow eye receiving either retrobulbar and subtenon or retrobulbar, subtenon and intravitreal; followed by intravenous.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from pre-procedure to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from pre-procedure to 12 months for reporting.

Closest Location

MD Stem Cells - Westport, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If under current medical therapy ( pharmacologic treatment) for a retinal or optic nerve disease be considered stable on that treatment and unlikely to have visual function improvement ( for example, glaucoma with intraocular pressure stable on topical medications but visual field damage ).
Have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.
You have objective, documented damage to the retina or optic nerve that is unlikely to improve. show original
You are at least 3 months post-surgical treatment intended to treat any ophthalmologic disease and stable. show original
You are over the age of 18. show original
You are medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. show original

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Optic Nerve Diseases by sharing your contact details with the study coordinator.