A multicenter double-blind randomized study to investigate the efficacy and tolerability of three doses of GS-101 eye drops, an antisense oligonucleotide, versus placebo on inhibition of corneal neovascularisation, a major risk factor of corneal graft rejection.
- Conditions
- Patients suffering from keratitis or keratouveitits of infectious origin
- Registration Number
- EUCTR2004-005015-29-DE
- Lead Sponsor
- es Laboratoires CTRS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Men or non-pregnant women.
At least 18 years old.
Suffering from keratitis or keratouveitis due to contact lens microbial keratitis, bacteria or other microorganisms, viruses, protozoa, immunologic diseases, trauma or prior surgery, alkali burns, graft rejection or degenerative disorders.
Evidence of documented progression of neovascularisation during a period of minimum 2 weeks and maximum 3 months before inclusion
Patients who are able to understand the protocol and give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Pregnancy.
Patients who cannot communicate reliably with the investigator.
Patients who are unlikely to cooperate with the requirements of the study
Patients who are unwilling and/or unable to give informed consent
Patients suffering from a life-threatening progressive disease
Patients participating in another clinical study
Patients who have used any other investigational drugs within 1 month of first dosing.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method