RTH258 6 mg in patients with retina damage such as growth of abnormal blood vessels
- Conditions
- Exudative senile macular degeneration of retinaMedDRA version: 18.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-004886-26-BE
- Lead Sponsor
- Alcon Research Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 660
•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
•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
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg with respect to the change in best-corrected visual acuity (BCVA) from Baseline to Week 48;Secondary Objective: To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg with respect to the change in BCVA from Baseline averaged over the period Week 36 to Week 48<br>To estimate the proportion of q12 subjects (1 injection every 12 weeks) and its predictive value up to Week 48 in the RTH258 6 mg treatment arm<br>To evaluate the efficacy of RTH258 6 mg relative to aflibercept 2 mg over the time period up to Week 96 by assessing changes in: BCVA, anatomical parameters and the q8 treatment need”<br>To assess visual function-related, subject reported outcomes.<br>To assess safety and tolerability of RT258 relative to the comparator<br>;Primary end point(s): Change in BCVA from baseline to week 48;Timepoint(s) of evaluation of this end point: Baseline, Week 48
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Average change in BCVA from Baseline over the period Week 36 through Week 48. For each subject, this endpoint is defined as the average of the changes from baseline to Weeks 36, 40, 44 and 48.<br>•q12 treatment status at Week 48 for subjects randomized to RTH258 6 mg.<br>•q12 treatment status at Week 48 within the subjects randomized to RTH258 6 mg, with no q8 need during the 1st q12 cycle (Week 16 and Week 20).<br>;Timepoint(s) of evaluation of this end point: Baseline, weeks 36, 40, 44 and 48<br>Week 48<br>Week 48