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: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-004886-26-GB
• Lead Sponsor: Alcon Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-01
• Study Completion: 2018-03-08
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 739

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:
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