Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients

NCT02568527 | Completed

• 1 other identifier: LVPEI-2012-11
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to undertake a pilot safety and efficacy study of a synthetic biodegradable membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure

Conditions

Limbal Stem Cell Deficiency

Keywords

LSCD; SLET; Donor Human Amniotic Membrane (hAM); PLGA

Outcome Measures

Primary Outcomes (6)

• Corneal Edema using Pachymetry

  At Baseline and at Month 12

  12 months

• Intraocular Pressure by Standard Applanation Tonometry

  At Baseline and at Month 12

  12 months

• Ocular Pain

  Magnitude of pain will assessed as patient reported outcome using Visual Analogue Scale (VAS) in a scale of 1 to 10 (Wong-Baker Faces Pain Rating Scale)

  12 months

• Schirmer's test (5 minute) without anesthesia

  12 months

• Clinical Laboratory Adverse Events

  12 months

• Vital Signs

  12 months

Secondary Outcomes (2)

• Regeneration of Stable Ocular Surface measured by Slit lamp Biomicroscopy Examination and Slit Lamp Photography

  12 months

• Best Corrected Visual Acuity by Snellen Chart

  12 months

Study Arms (1)

PLGA Scaffold

EXPERIMENTAL

Poly Lactide-co-Glycolic Acid (PLGA) 50:50

Device: PLGA scaffold

Interventions

PLGA scaffold DEVICE

Poly-Lactic-co-Glycolic Acid (50:50) biodegradable, synthetic scaffold

Also known as: Purasorb PDLG 5004

PLGA Scaffold

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants who are ≥18 years of age.
• Patients having a confirmed diagnosis of total LSCD as confirmed by any one or all of the following:
• In-growth of conjunctival epithelium over the cornea (conjunctivalization),
• o absence of limbal Palisades of Vogt,
• A fine stippled appearance on fluorescein staining,
• Persistent or recurrent corneal epithelial defects
• Superficial vascularization,
• Dull and irregular corneal epithelium.
• Participants having unilateral limbal stem cell deficiency due to chemical injury
• No prior history of limbal transplantation
• No ongoing and other active ocular pathology
• No severe pathological and psychological conditions that might interfere with the patients participation in the study
• Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice.

You may not qualify if:

• Bilateral LSCD
• LSCD due to autoimmune disorders and partial LSCD
• Having other ongoing ocular pathologies and acute ocular inflammation
• Previous neoplastic/cancer disease
• Severe dry eyes confirmed by Schirmer's test
• Acute systemic infections
• Prior history of limbal transplantation surgery or multiple surgeries in the limbal region
• Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results.
• Any uncontrolled, inter-current illness that in the opinion of the Investigator may interfere with study evaluation.
• Participants with uncontrolled diabetes will be excluded from the study
• History or evidence of cardiac disease: congestive heart failure; New York Heart Association (NYHA) class 2 or greater (see Appendix 6); active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization.
• Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
• Reproductive age patients not practicing effective and adequate birth control measures
• Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study.
• Previous participation in this study

Sponsors & Collaborators

• Virender S Sangwan, MBBS, MS: lead
• Wellcome Trust: collaborator
• University of Sheffield: collaborator

Study Sites (1)

LV Prasad Eye Institute

Hyderabad, Andhra Pradesh, 500034, India

Location

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Virender S Sangwan, MBBS MS

  LV Prasad Eye Institute

  PRINCIPAL INVESTIGATOR

• Sayan Basu, MBBS MS

  LV Prasad Eye Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Center for Ocular Regeneration (CORE)

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: October 6, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: July 1, 2018
• Last Updated: August 9, 2018

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)