Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Topical IL-1-Ra for Treatment of Corneal Neovascularization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00915590
First received: June 4, 2009
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to determine the effectiveness and safety of topical Interleukin-1-Receptor Antagonist in treatment of corneal neovascularization.


Condition Intervention Phase
Corneal Neovascularization
Drug: Placebo
Drug: IL-1Ra
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Topical IL-1-Ra for Treatment of Corneal Neovascularization

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Changes in the extent of corneal NV at Week 6, 12, 24 and 64 by measurement of: Neovascular Area (NA) Vessel Caliber (VC) Invasion Area (IA) [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Best Spectacle-Corrected Visual Acuity (BSCVA) at Week-6, 12, 24, 64 and central corneal thickness at Week-6, 12, 24, 64 [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm 1
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
Experimental: Treatment Arm 2
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915590

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00915590     History of Changes
Other Study ID Numbers: 09-03-017
Study First Received: June 4, 2009
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Corneal Neovascularization
Neovascularization, Pathologic
Corneal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014