RTH258 6 mg in patients with retina damage such as growth of abnormal blood vessels

Phase 1

• Conditions: Exudative senile macular degeneration of retina; MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-004886-26-IT
• Lead Sponsor: ALCON RESEARCH. LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-10
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

•Subjects must give written informed consent
•Subjects must be 50 years of age or older
•Active CNV lesions secondary to AMD that affect the central subfield in
the study eye
•Total area of CNV must comprise as stated in the protocol
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 614

Exclusion Criteria

•Any active intraocular or periocular infection or active intraocular
inflammation in either eye
•Central subfield of the study eye affected by fibrosis or geographic
atrophy
•Subject has received any approved or investigational treatment for
neovascular AMD (other than vitamin supplements) in the study eye at
any time.
•History or evidence of the following in the study eye:
• Intraocular or refractive surgery
•Uncontrolled glaucoma as defined in the protocol
•Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®) or
pegaptanib (MACUGEN®) within the 4 week period prior to Baseline, or
with Ranibizumab, 0.5 mg (LUCENTIS®) within the 2 week period prior
to Baseline
•Stroke or myocardial infarction or uncontrolled blood pressure
Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified