Topical IL-1-Ra for Treatment of Corneal Neovascularization

NCT00915590 | Terminated Phase 1 Results

• 2 other identifiers: 09-03-017Protocol #09-03-017
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effectiveness and safety of Interleukin-1-Receptor Antagonist eye drops for the treatment of corneal blood vessels.

Conditions

Corneal Neovascularization

Outcome Measures

Primary Outcomes (4)

• Incidence and Severity of Ocular Adverse Event

  Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.

  64 Weeks

• Extent of Neovascular Area (NA)

  The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.

  64 weeks

• Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels

  The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.

  64 Weeks

• Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels

  The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.

  64 Weeks

Secondary Outcomes (2)

• Best Spectacle-Corrected Visual Acuity (BSCVA)

  64 weeks

• Central Corneal Thickness

  64 Weeks

Study Arms (2)

Placebo first, then IL-1RA

EXPERIMENTAL

It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.

Drug: Placebo; Drug: IL-1Ra

IL-1RA first, then Placebo

EXPERIMENTAL

It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo

Drug: Placebo; Drug: IL-1Ra

Interventions

Placebo DRUG

Custom eye drop eye three times a day in both eyes for a period of 6 weeks

IL-1RA first, then Placebo; Placebo first, then IL-1RA

IL-1Ra DRUG

5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

Also known as: Kineret

IL-1RA first, then Placebo; Placebo first, then IL-1RA

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
• Patients with superficial or deep corneal NV that extends farther than 1 mm from the limbus

You may not qualify if:

• Corneal or ocular surface infection within 30 days prior to study entry• Ocular or periocular malignancy
• Contact lens (excluding bandage contact lens) use within 2 weeks prior to study entry
• Persistent epithelial defect (\>1mm and ≥14 days duration) within 2 weeks prior to study entry
• Intravitreal or periocular steroids within 2 weeks prior to study entry
• Change in dose/frequency of topical steroids and/or NSAIDs within 2 weeks prior to study entry
• Pregnancy (positive pregnancy test) or lactation
• Premenopausal women not using contraception
• Signs of current infection, including fever and current treatment with antibiotics
• Participation in another simultaneous medical investigation or trial

Sponsors & Collaborators

• Reza Dana, MD: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Corneal Neovascularization

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Enrollment goal for this study was set at 20 participants (10 for each treatment arm). After an interim analysis, the Principal Investigator decided to terminate the study and stop enrollment.

Results Point of Contact

• Title: Reza Dana, MD, MPH, MSc
• Organization: Massachusetts Eye and Ear Infirmary

Cornea_Research@meei.harvard.edu

617-573-3313

Study Officials

• Reza Dana, MD, MPH, MSc

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 8, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 8, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)