Clinical trial NCT02749734: Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
Official title: Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Macular Degeneration
Stargardt's Macular Dystrophy
Keywords: Human embryo stem cell derived retinal pigment epitheliums
Subretinal transplantation
Wet Age related Macular degeneration
Stargardt's macular dystrophy
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).


Eligibility criteria: Inclusion Criteria:

* Aging from 18 to 75 years
* must have signed informed consent
* At least one visually impaired eye caused by macular degeneration diseases
* Can not be effectively treated with conventional therapies
* Best corrected visual acuity scores between 19 and 73 letter in ETDRs (early treatment diabetic retinopathy ) eye chart , including 19 and 73 (or the equivalent of Snellen eyesight from 20/400 to 20/40)
* Visual loss caused by macular degeneration diseases

Exclusion Criteria:

* Eyes with concomitant diseases which will interfere the visual improvement of the study
* Active intraocular inflammation regardless of the grade of severity
* Active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, ophthalmia)
* History of uveitis
* Severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction
* Iris neovascularization
* Patients who have only one functioning eye, or the best corrected vision of untreated eye scores less than 24 letters in ETDRS chart(corresponding to 20/320 in Snellen chart)
* History of intraocular surgery
* Severe systemic diseases: Stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis
* Allergic to sodium fluorescein
* Uncontrolled hypertension (systolic pressure\>140mmHg,or diastolic pressure\>90mmHg)
* Coagulative function disorder
* System administration of drugs that are toxic to lens, retina, or optic nerve like hydroxychloroquine, phenothiazine, ethambutol, tamoxifen, etc.
* Involved in other clinical trials of any medicine within 1 month (or within 5 half-life periods)
* Have maternity plan in 6 months
* In pregnancy or lactation period.

Primary outcomes:
measure: Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]
timeFrame: up to 12 months
Secondary outcomes:
measure: Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize
timeFrame: up to 12 months
measure: Visual Field as examined by Static perimetry
timeFrame: up to 12 months
measure: Flash Electroretinogram (FERG)
timeFrame: up to 12 months
measure: Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)
timeFrame: up to 12 months
measure: Multifocal Electroretinogram (MFERG)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
References: