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Efficacy and Safety of RTH258 Versus Aflibercept

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ClinicalTrials.gov Identifier: NCT02307682
Recruitment Status : Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

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

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 8, 2014
Primary Completion Date : April 22, 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: RTH258 Dose A
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
Experimental: RTH258 Dose B
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
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®


Outcome Measures

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

Secondary Outcome Measures :
  1. Average Change in BCVA from Baseline over the Period Week 36 through Week 48 [ Time Frame: Baseline, Week 36 through Week 48 ]
  2. Proportion of patients with positive q12 treatment status up to Week 96 [ Time Frame: Up to Week 96 ]
    Positive treatment status is defined as IVT injections per planned dosing regimen (every 12 weeks (q12)). This outcome measure is prespecified for RTH258 3 mg and 6 mg only.

  3. Proportion of patients with positive q12 treatment status at Week 48 within the subjects with no q8 (every 8 weeks) treatment need during the first q12 cycle (Week 16, Week 20) [ 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 3 mg and 6 mg only.

  4. Change in BCVA from Baseline at Each Postbaseline Visit [ Time Frame: Baseline, up to Week 96 ]
  5. Average Change in BCVA from Baseline over the Period Week 4 to Week 48/96 [ Time Frame: Baseline, Week 4 to Week 96 ]
  6. Average Change in BCVA from Baseline over the Period Week 12 to Week 48/96 [ Time Frame: Baseline, Week 12 to Week 96 ]
  7. Average Change in BCVA from Baseline over the Period Week 84 to Week 96 [ Time Frame: Baseline, Week 84 to Week 96 ]
  8. Gain in BCVA of 15/10/5 Letters or More from Baseline to each Postbaseline Visit [ Time Frame: Baseline, up to Week 96 ]
  9. Loss in BCVA of 15/10/5 Letters or More from Baseline to each Postbaseline Visit [ Time Frame: Baseline, up to Week 96 ]
  10. Change in Central Subfield Thickness (CSFT) from Baseline to each Postbaseline Visit [ Time Frame: Baseline, up to Week 96 ]
  11. Change in CNV Lesion Size from Baseline to up to Week 96 [ Time Frame: Baseline, up to Week 96 ]
  12. Absence of Subretinal Fluid at each Postbaseline Visit [ Time Frame: Up to Week 96 ]
  13. Absence of Intraretinal Fluid at each Postbaseline Visit [ Time Frame: Up to Week 96 ]
  14. Absence of Sub Retinal Pigment Epithelium (RPE) Fluid at each Postbaseline Visit [ Time Frame: Up to Week 96 ]
  15. Percentage of Subjects with q8 Treatment Need Status at Weeks 16, 20, 32, 44, 56, 68, 80, and 92 [ Time Frame: Up to Week 92 ]
    Investigator will assess whether a subject needs treatment q8 at the pre-specified visits.

  16. Change in Patient Reported Outcomes from Baseline up to Week 96 [ Time Frame: Baseline, up to Week 96 ]
  17. Change in Neurosensory Retinal Thickness from Baseline at Each Postbaseline Visit [ Time Frame: Baseline, Up to Week 96 ]
  18. Proportion of patients with positive q12 treatment status at Week 96 within the subjects with no q8 need during the first q12 cycle (Week 16, Week 20) [ 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 3 mg and 6 mg only.


Eligibility Criteria

Information from the National Library of Medicine

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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®), 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
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): NCT02307682


Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Siobhan Garbutt, Clinical Manager Alcon Research
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02307682     History of Changes
Other Study ID Numbers: RTH258-C001
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: May 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