A Study of Implantation of Retinal Pigment Epithelium in Subjects with Acute Wet Age Related Macular Degeneration

NCT01691261 | Completed Phase 1 DMC

• 2 other identifiers: DACL10102011-005493-37
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related macular degeneration in whom there is rapidly progressing vision loss

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events.

  The number of Adverse Events (AE) and Serious Adverse Events (SAE) noted during the study and an assessment of whether they are trial product related

  52 weeks

• Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more at Week 24.

  The number of patients with a difference between the baseline BCVA and BCVA at 24 weeks in ETDRS letters, where the differences is 15 letters or more, as a percentage of the total number of cases.

  24 weeks

Secondary Outcomes (9)

• Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more

  Weeks 1,2,4,8, 12,16, 36, 52

• Mean change of best corrected visual acuity (BCVA) from baseline by study visit.

  52 weeks

• Position of PF-05206388 by serial biomicroscopic evaluation.

  Day 2 and Weeks 1, 2, 4, 8, 10, 12, 16, 24, 36, 52

• Position and presence of pigmented RPE cells by serial fundus photography

  Weeks 2, 4, 8, 10, 12, 16, 24, 36, 52

• Mean change from baseline in contrast sensitivity by Pelli Robson test

  Weeks 24, 52

Study Arms (1)

Treatment

EXPERIMENTAL

PF-05206388 Retinal Pigment Epithelium living tissue equivalent for intraocular use in the form of a monolayer of Retinal Pigmented Epithelial (RPE) cells immobilized on a polyester membrane

Biological: PF-05206388

Interventions

PF-05206388 BIOLOGICAL

PF-05206388 will be provided as a Retinal Pigment Epithelium living tissue equivalent for intraocular use in the form of a monolayer of Retinal Pigmented Epithelial (RPE) cells immobilized on a polyester membrane. The membrane is approximately 6 mm x 3 mm and will contain a confluent layer of RPE cells, at a nominal dose of 17 mm2. The implant is intended to be life-long.

Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and /or post-menopausal female subjects aged 60 years or above.
• Diagnosis of wet Age-related Macular Degeneration (AMD) plus rapid recent vision decline
• An informed consent document signed and dated by the subject or a legal representative.

You may not qualify if:

• Pregnant females; breastfeeding females; and females of childbearing potential.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
• Current or previous significant other ocular disease in the study eye, as determined by the investigator.

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• University College, London: collaborator

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Moorfields

  Moorfields Eye Hospital NHS Foundation Trust

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 24, 2012
• Study Start: October 14, 2021
• Primary Completion: October 10, 2023
• Study Completion: June 24, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)