NCT02868424

Brief Summary

Early Phase I Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD) Patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Feb 2016

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

August 8, 2016

Last Update Submit

June 14, 2017

Conditions

Age Related Macular DegenerationMacular DegenerationAMD

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with adverse events

    Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period.

    Two years following transplantation

Secondary Outcomes (3)

  • Assessment of standardized ETDRS acuity testing

    Two years following transplantation

  • Assessment of visual function changes

    Two years following transplantation

  • Assessment of systemic condition

    Two years following transplantation

Study Arms (1)

fRPE cells

EXPERIMENTAL

Subretinal transplantation of fRPE cells in experimental eye

Drug: fRPE cells

Interventions

fRPE cellsDRUG

fRPE cells transplantation directly into the subretinal space of one eye (experimental eye) in a single transplant procedure

Also known as: human fetal retinal pigment epithelial cells
fRPE cells

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of dry AMD or non-exudative AMD (geographical atrophy\>250μm, involving central fovea of macular; or AMD with fibrous disciform scar and maintained stationary for at least 3 months)
  • Experimental eye with best-corrected visual acuity (BCVA) of no more than 20/400 and control eye with BCVA of more than or equal to 20/400
  • Patients are in good state
  • Patient understand and sign the consent form.

You may not qualify if:

  • Blood routine examination is abnormal (hemoglobin\<10gm/dL; blood platelet count\<100k/mm³; neutrophil count\<1000/mm³)
  • Blood biochemistry is abnormal (ALT／AST\>1.5; creatinine\>1.3mg/dL)
  • Experimental eye has optic nerve atrophy caused by glaucoma
  • Patients need cataract surgery within a year
  • Patients have received cataract surgery and other ocular surgery in recent 3 months
  • Experimental eye has retinal detachment, or has received retinal detachment surgery.
  • Patients with uveitis and other endophthalmitis
  • Patients with other ocular disease affecting vision.
  • Patients have participated in clinical study of ocular or systemic drug use in recent 6 months.
  • Patients with medical history of malignant cancer (except resected basal cell carcinoma and squamous-cell carcinoma).
  • Patients with medical history of myocardial infarction
  • Patient with diabetes
  • Patient with Parkinson disease or Alzheimer's disease
  • Patients are under the treatment of immunosuppressive agent (except intermittent, low-dose corticosteroid treatment).
  • Patients with other medical conditions that restricts the compliance and safety of patients, or affects experimental results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Qinghuai Liu, M.D.

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 16, 2016

Study Start

February 13, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

June 16, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations

CN(1)