NCT02464956

Brief Summary

No treatments exist for Age-related Macular Degeneration (AMD) when there is cell loss such as in late wet AMD or dry AMD. The differentiation of RPE cells from patient derived iPSC will offer valuable source of tissue for transplantation in these forms of AMD and may form basis for a future treatment option in terms of cell transplantation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Status
completed

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

First Submitted

Initial submission to the registry

May 14, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 12, 2022

Status Verified

September 1, 2021

Enrollment Period

2.7 years

First QC Date

May 14, 2015

Last Update Submit

April 4, 2022

Conditions

Age Related Macular Degeneration (AMD)

Outcome Measures

Primary Outcomes (1)

  • Successful production of a Retinal Epithelial (RPE) layer that fulfils Regulatory Regulation for transplantation. This will be confirmed with standard laboratory characterisation of RPE and completed toxicity and safety studies on the cell layer.

    1 year

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by Age Related Macular Degeneration (AMD)

You may qualify if:

  • Subjects over the age of 18 years
  • Subjects with the ability to give informed consent
  • Subjects with known AMD (both wet and dry)

You may not qualify if:

  • Unable to give informed consent
  • Subjects unable to give blood sample for medical reasons
  • Subjects with coagulopathies
  • Subjects who are known to be at risk of keloid scarring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sample and a skin sample will be collected from the study participants

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2015

First Posted

June 8, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

April 12, 2022

Record last verified: 2021-09