Stem Cell Ophthalmology Treatment Study II

ConditionsRetinal Disease Age-Related Macular Degeneration Retinitis Pigmentosa Stargardt Disease Optic Neuropathy Nonarteritic Ischemic Optic Neuropathy Optic Atrophy Optic Nerve Disease Glaucoma Leber Hereditary Optic Neuropathy Blindness Vision Loss Night Vision Loss Partial Vision, Low Retinopathy Maculopathy Macular Degeneration Retina Atrophy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMD Stem Cells

About this trial

This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have objective, documented damage to the retina or optic nerve unlikely to improve OR

Have objective, documented damage to the retina or optic nerve that is progressive AND have less than or equal to 20/30 best corrected central visual acuity in one or both eyes AND/OR an abnormal visual field in one or both eyes.

Be at least 3 months post-surgical treatment intended to treat any ophthalmologic disease and stable.

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 ).

Disqualifiers

Patients who are not capable of an adequate ophthalmologic examination or evaluation to document the pathology.

Patients who are not capable or not willing to undergo follow up eye exams with the principle investigator or their ophthalmologist or optometrist as outlined in the protocol.

Patients who are not capable of providing informed consent.

Patients who may be at significant risk to general health or to the eyes and visual function should they undergo the procedure.

Trial design

Design model

Single group

Treatments tested in this trial

Arm 1
Procedure/Surgery
Procedure/ Surgery: RB (Retrobulbar) Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: ST (Subtenon) Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: IV (Intravenous) Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: Arm 1Other 1 intervention

Trial outcomes

Primary outcomes

Visual Acuity

Best corrected visual acuity will be measured with Snellen Eye Chart and the ETDRS (Early Treatment Diabetic Retinopathy Study)Eye Chart when available at each post- procedure visit. Intervals at minimum will be first post- procedure day,then 3 months, 6 months and 12 months post-procedure day. Recommended visit 1 month post -procedure day.

Time frame

Change from pre-procedure to 12 months

Secondary outcomes

Visual Fields

Visual fields will be evaluated with automated perimetry during post- procedure visits as needed and specifically at 6 months and 12 months. Visual fields are a key measurement in patients with peripheral vision loss.

Time frame

Change from pre-procedure to 12 months

Optical Coherence Tomography (OCT)

OCT thickness of the retinal nerve fiber layer the optic nerve and/or macula during the post- procedure visits as needed and specifically at 6 and 12 months - if available.

Time frame

Change from pre-procedure to 12 months