Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

NCT01582880 | Completed Phase 1 Results

• 1 other identifier: 10-03-020
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).

Conditions

Chemical Injuries; Unspecified Complication of Corneal Transplant; Autoimmune Diseases; Ocular Cicatricial Pemphigoid; Stevens Johnson Syndrome; Lupus Erythematosus, Systemic; Rheumatoid Arthritis; Other Autoimmune Diseases

Keywords

Keratoprosthesis; sterile cornea ulcer

Outcome Measures

Primary Outcomes (2)

• Changes in Corneal Thickness at 1 Millimeter

  The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.

  measured at week 4, 6, 26, 32, 52

• Changes in Corneal Thickness at 2 Millimeter

  The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.

  measured at week 4, 6, 26, 32, 52

Secondary Outcomes (3)

• Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers

  post op week 52

• Ocular Safety

  measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52

• Systemic Safety

  measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52

Study Arms (1)

Riboflavin Cross-linked donor cornea

EXPERIMENTAL

the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Drug: Riboflavin

Interventions

Riboflavin DRUG

Used to treat donor cornea before implantation

Also known as: Riboflavin (vitamin B2) 0.1% solution

Riboflavin Cross-linked donor cornea

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Age \> 18 years.
• A negative urine pregnancy test.
• Candidate for a Boston Keratoprosthesis/Corneal transplant.
• Generally good stable overall health.
• Patients with an eye at risk for a cornea sterile ulcer which includes:
• Chemical injuries.
• Autoimmune diseases (ocular cicatricial pemphigoid, Stevens Johnson Syndrome, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune diseases).
• History of previous sterile corneal ulceration requiring a cornea transplant.

You may not qualify if:

• Age \< 18 years.
• Inability to provide written informed consent and comply with study assessments for the full duration of the study.
• Pregnant or lactating women.
• No or minimal tear production.
• Ocular or periocular malignancy.
• Inability to wear a contact lens due to lid abnormalities or shortened fornix.
• Signs of current infection, including fever and current treatment with antibiotics.
• Participation in another simultaneous medical investigation or trial

Sponsors & Collaborators

• Joseph B. Ciolino, MD: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Autoimmune Diseases; Pemphigoid, Benign Mucous Membrane; Stevens-Johnson Syndrome; Lupus Erythematosus, Systemic; Arthritis, Rheumatoid

Interventions

Riboflavin; Solutions

Condition Hierarchy (Ancestors)

Immune System Diseases; Conjunctival Diseases; Eye Diseases; Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Erythema Multiforme; Erythema; Hypersensitivity, Delayed; Hypersensitivity; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Connective Tissue Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Joseph Ciolino, MD
• Organization: Massachusetts Eye and Ear Infirmary

joseph_ciolino@meei.harvard.edu

617-573-4437

Study Officials

• Joseph Ciolino, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 23, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 21, 2019
• Results First Posted: July 24, 2017

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)