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Efficacy and Safety of RTH258 Versus Aflibercept - Study 2

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02434328
First Posted: May 5, 2015
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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.

Condition Intervention Phase
Neovascular Age-Related Macular Degeneration Drug: RTH258 solution for IVT injection Drug: Aflibercept solution for IVT injection Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in Best Corrected Visual Acuity (BCVA) from Baseline at Week 48 [ Time Frame: Baseline, Week 48 ]

Secondary Outcome Measures:
  • 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 ]
    Positive treatment status is defined as IVT injections per planned dosing regimen (every 12 weeks (q12)). This outcome measure is prespecified for RTH258 6 mg only.

  • Proportion of patients with positive q12 treatment status at Week 96 [ Time Frame: Up to Week 96 ]
    Positive treatment status is defined as IVT injections per planned dosing regimen (q12). This outcome measure is prespecified for RTH258 6 mg only.

  • 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 ]
    Investigator will assess whether a subject needs treatment every 8 weeks (q8) at the pre-specified visits.

  • 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 ]
    Positive treatment status is defined as IVT injections per planned dosing regimen (q12). This outcome measure is prespecified for RTH258 6 mg only.


Estimated Enrollment: 1200
Study Start Date: July 28, 2015
Estimated Study Completion Date: March 2018
Primary Completion Date: April 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RTH258
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
Drug: RTH258 solution for IVT injection
Administered as a 6 mg/50 µL dose
Active Comparator: Aflibercept
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
Drug: Aflibercept solution for IVT injection
Administered as a 2 mg/50 µL dose
Other Name: EYLEA®

Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434328


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Group Trial Lead Novartis Pharmaceuticals
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02434328     History of Changes
Other Study ID Numbers: RTH258-C002
2014-004886-26 ( EudraCT Number )
First Submitted: March 27, 2015
First Posted: May 5, 2015
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Alcon Research:
AMD
CNV
IVT

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions