Double-Blind randomized study in patients with neovascularization of the cornea of the eye using treatment with a new medication called GS101 eyedrops or placebo.

A MULTICENTRE DOUBLE-BLIND RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF GS-101 EYE DROPS, AN ANTISENSE OLIGONUCLEOTIDE, VERSUS PLACEBO ON INHIBITION OF CORNEAL NEOVASCULARIZATION, A MAJOR RISK FACTOR OF CORNEAL GRAFT REJECTION: The I-CAN study. - The I-CAN study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005388-33-DE

Enrollment

Registered

2008-10-30

Start date

2009-02-03

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with corneal neovascularization, a major risk factor of corneal graft rejection.

Interventions

Product Name: GS-101 Product Code: GS-101 Pharmaceutical Form: Eye drops INN or Proposed INN: Oligonucleotide Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men or non-pregnant women (only women who are post-menopausal, surgically sterile or practicing a reliable contraception). At least 18 years old. Suffering from keratitis or kerato-uveitis of bacterial, viral (e.g. herpes), or traumatic (e.g. alkali burns) origin. Evidence of documented progression of stromal neovascularization during a minimum period of 1 week and maximum of 2 months and corneal vessels reaching out for at least 2,5 mm from the limbus and/or reaching the cornea center. Visual acuity >.01 and =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Pregnancy: a urinary test for pregnancy must be performed in female patients before inclusion in the study. 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate clinical benefit on visual acuity (VA).;Secondary Objective: To demonstrate regression and inhibition of additional corneal angiogenesis with GS-101 eye drops in patients suffering from keratitis or kerato-uveitis of bacterial , viral (e.g. herpes), or traumatic (e.g. alkali burns) origin leading to potentional corneal graft indication. To demonstrate additional clinical benefit on quality of life (QoL), need for transplantation, and risk of graft rejection after potential future transplantation. To assess the safety and tolerability of GS-101.;Primary end point(s): Visual Acuitiy (VA);Timepoint(s) of evaluation of this end point: At screening, inclusion and after 1, 3 and 6 months	—

Measure

Time frame

Main Objective: To demonstrate clinical benefit on visual acuity (VA).;Secondary Objective: To demonstrate regression and inhibition of additional corneal angiogenesis with GS-101 eye drops in patients suffering from keratitis or kerato-uveitis of bacterial , viral (e.g. herpes), or traumatic (e.g. alkali burns) origin leading to potentional corneal graft indication. To demonstrate additional clinical benefit on quality of life (QoL), need for transplantation, and risk of graft rejection after potential future transplantation. To assess the safety and tolerability of GS-101.;Primary end point(s): Visual Acuitiy (VA);Timepoint(s) of evaluation of this end point: At screening, inclusion and after 1, 3 and 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): growth of vessels;Timepoint(s) of evaluation of this end point: At screening, inclusion and after 1, 3 and 6 months	—

Countries

France, Germany, Switzerland

Contacts

Public ContactAntoine Ferry

Les Laboratoires CTRS

ctrs@club-internet.fr+33 1 41 22 02 36

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026