Efficacy and Safety of RTH258 Versus Aflibercept



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:5/12/2018
Start Date:December 8, 2014
End Date:March 28, 2018

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A Two-Year, Randomized, Double-Masked, Multicenter, Three-Arm Study Comparing the Efficacy and Safety of RTH258 Versus Aflibercept in Subjects With Neovascular Age-Related Macular Degeneration

The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT)
injection at two dosage levels to aflibercept solution for IVT injection (2 mg) 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 Argentina, Australia,
Brazil, Canada, Chile, Colombia, Costa Rica, Guatemala, Israel, Japan, Mexico, Panama, Peru,
New Zealand, and US (including Puerto Rico).

This study has 3 arms with a 1:1:1 randomization. Subjects in all arms will have visits every
4 weeks through Week 96. The primary analysis will be performed at Week 48.

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®), ranibizumab (LUCENTIS®),
or pegaptanib (MACUGEN®) 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 effective
methods of contraception during dosing of study treatment

- Stroke or myocardial infarction in the 90 day 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
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