Trial record 2 of 53 for:    dira

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

ClinicalTrials.gov processed this record on April 17, 2014