Overview

This trial is active, not recruiting.

Condition neovascular age-related macular degeneration
Treatments rth258 solution for ivt injection, aflibercept solution for ivt injection
Phase phase 3
Target VEGF
Sponsor Alcon Research
Start date July 2015
End date June 2017
Trial size 1200 participants
Trial identifier NCT02434328, 2014-004886-26, RTH258-C002

Summary

The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT) injection to aflibercept solution for IVT injection in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye. This study will be conducted in the following countries: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Sweden, Switzerland, Taiwan, Turkey, and the United Kingdom.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
RTH258 solution for IVT injection, single injection at Day 0, Week 4, and Week 8, then as specified in the protocol up to Week 92
rth258 solution for ivt injection
Administered as a 6 mg/50 µL dose
(Active Comparator)
Aflibercept solution for IVT injection, single injection at Day 0, Week 4, and Week 8, then as specified in the protocol up to Week 92
aflibercept solution for ivt injection EYLEA®
Administered as a 2 mg/50 µL dose

Primary Outcomes

Measure
Change in Best Corrected Visual Acuity (BCVA) from Baseline at Week 48
time frame: Baseline, Week 48

Secondary Outcomes

Measure
Average Change in BCVA from Baseline over the Period Week 36 through Week 48
time frame: Baseline, Week 36 through Week 48
Proportion of patients with positive q12 treatment status at Week 48
time frame: Up to Week 48
Proportion of patients with positive q12 treatment status at Week 96
time frame: Up to Week 96
Change in BCVA from Baseline at Each Postbaseline Visit
time frame: Baseline, Up to Week 96
Average Change in BCVA from Baseline over the Period Week 4 to Week 48/96
time frame: Baseline, Week 4 to Week 48/96
Average Change in BCVA from Baseline over the Period Week 12 to Week 48/96
time frame: Baseline, Week 12 to Week 48/96
Average Change in BCVA from Baseline over the Period Week 84 to Week 96
time frame: Baseline, Week 84 to Week 96
Gain in BCVA of 15/10/5 Letters or More from Baseline to each Postbaseline Visit
time frame: Baseline, Up to Week 96
Loss in BCVA of 15/10/5 Letters or More from Baseline to each Postbaseline Visit
time frame: Baseline, Up to Week 96
Change in Central Subfield Thickness (CSFT) from Baseline to each Postbaseline Visit
time frame: Baseline, Up to Week 96
Change in CNV Lesion Size from Baseline to up to Week 96
time frame: Baseline, Up to Week 96
Absence of Subretinal Fluid at each Postbaseline Visit
time frame: Up to Week 96
Absence of Intraretinal Fluid at each Postbaseline Visit
time frame: Up to Week 96
Percentage of Subjects with q8 Treatment Need Status at Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, and 92
time frame: Up to Week 92
Change in Patient Reported Outcomes from Baseline up to Week 96
time frame: Baseline, Up to Week 96
Change in Neurosensory Retinal Thickness from Baseline at Each Postbaseline Visit
time frame: Baseline, Up to Week 96
Proportion of patients with positive q12 treatment status at Week 96 within the subjects with no q8 need during the 1st q12 cycle (Week 16, Week 20)
time frame: Week 96

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Provide written informed consent - Active CNV lesions secondary to AMD in the study eye - Intra and/or subretinal fluid affecting the central subfield of the study eye - BCVA between 78 and 23 letters, inclusive, in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) testing - Other protocol-defined inclusion criteria may apply Exclusion Criteria: - Any active intraocular or periocular infection or active intraocular inflammation in either eye - Fibrosis or geographic atrophy - Any approved or investigational treatment for neovascular AMD (other than vitamin supplements) in the study eye at any time - Any history or evidence of a concurrent intraocular condition in the study eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the course of the study to prevent or treat visual loss - Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks - History or evidence of surgery to the study eye, as specified in the protocol - Uncontrolled glaucoma in the study eye - Aphakia and/or absence of the posterior capsule in the study eye - Use of corticosteroids, ocular and systemic, as specified in the protocol - Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®), pegaptanib (MACUGEN®), or ranibizumab (LUCENTIS®) in the nonstudy eye, as specified in the protocol - History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product - History of hypersensitivity to any component of the test article, control article, or ophthalmic dye, as assessed by the Investigator - Pregnant, lactating, or women of child-bearing potential, unless using highly effective methods of contraception during dosing of study treatment - Stroke or myocardial infarction in the 6 month period prior to enrollment - Uncontrolled blood pressure defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg - Participation in an investigational drug, biologic, or device study, as specified in the protocol - Other protocol-defined exclusion criteria may apply

Additional Information

Official title A Two-Year, Randomized, Double-Masked, Multicenter, Two-Arm Study Comparing the Efficacy and Safety of RTH258 6 mg Versus Aflibercept in Subjects With Neovascular Age-Related Macular Degeneration
Description This study has 2 arms with a 1:1 randomization. Subjects in all arms will have visits every 4 weeks through Week 96. The primary analysis will be performed at Week 48.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Alcon Research.