Topical IL-1-Ra for Treatment of Corneal Neovascularization

• ClinicalTrials.gov Identifier: NCT00915590
• Recruitment Status: Terminated
• First Posted: June 8, 2009
• Results First Posted: May 8, 2017
• Last Update Posted: May 8, 2017
• Sponsor: Reza Dana, MD
• Information provided by (Responsible Party): Reza Dana, MD, Massachusetts Eye and Ear Infirmary

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Corneal Neovascularization	Drug: Placebo; Drug: IL-1Ra	Phase 1; Phase 2

Detailed Description:

Normally avascular, under many pathologic conditions, vessels may invade the cornea from the limbal vascular plexus. Infection, inflammation, ischemia, degeneration, or trauma, and the loss of the limbal stem cell barrier can cause corneal neovascularization. Growth of new vessels may result in corneal scarring, edema, lipid deposition, and inflammation that may alter visual acuity and is a leading cause of monocular visual impairment and blindness. Additionally, it results in the loss of immune response across the cornea, thereby worsening the prognosis of a subsequent penetrating keratoplasty (PK). Growth of new blood and lymphatic vessels from preexisting vessels are mediated by members of the vascular endothelial growth factor (VEGF) family. This study is designed to investigate whether Interleukin-1-Receptor Antagonist is a drug that is both safe and effective in blocking VEGF pathways, stopping new growth, and reducing old vessel growth.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Topical IL-1-Ra for Treatment of Corneal Neovascularization
• Study Start Date: April 2009
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Placebo first, then IL-1RA; 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; Custom eye drop eye three times a day in both eyes for a period of 6 weeks; Drug: IL-1Ra; 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks; Other Name: Kineret
Experimental: IL-1RA first, then Placebo; 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; Custom eye drop eye three times a day in both eyes for a period of 6 weeks; Drug: IL-1Ra; 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks; Other Name: Kineret

Outcome Measures

Primary Outcome Measures :

1. Incidence and Severity of Ocular Adverse Event [ Time Frame: 64 Weeks ]
   Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
2. Extent of Neovascular Area (NA) [ Time Frame: 64 weeks ]
   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.
3. Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels [ Time Frame: 64 Weeks ]
   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.
4. Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels [ Time Frame: 64 Weeks ]
   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.

Secondary Outcome Measures :

1. Best Spectacle-Corrected Visual Acuity (BSCVA) [ Time Frame: 64 weeks ]
   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.
2. Central Corneal Thickness [ Time Frame: 64 Weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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
• Patients are in generally good stable overall healthExclusion Criteria: • Has received treatment with anti-VEGF agents (topical, intraocular or systemic) within 30 days of study entry
• 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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Reza Dana, MD

Investigators

• Principal Investigator: Reza Dana, MD, MPH, MSc; Massachusetts Eye and Ear Infirmary

More Information

• Responsible Party: Reza Dana, MD, Principal Investigator, Massachusetts Eye and Ear Infirmary
• ClinicalTrials.gov Identifier: NCT00915590
• Other Study ID Numbers: 09-03-017; Protocol #09-03-017 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
• First Posted: June 8, 2009
• Results First Posted: May 8, 2017
• Last Update Posted: May 8, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Additional relevant MeSH terms:

Corneal Neovascularization; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Corneal Diseases; Eye Diseases; Interleukin 1 Receptor Antagonist Protein; Antirheumatic Agents