We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

X-82 to Treat Age-related Macular Degeneration

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02348359
First Posted: January 28, 2015
Last Update Posted: January 13, 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):
Tyrogenex
  Purpose
The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.

Condition Intervention Phase
Age-Related Macular Degeneration (AMD) Macular Degeneration Exudative Age-related Macular Degeneration AMD Macular Degeneration, Age-related, 10 Eye Diseases Retinal Degeneration Retinal Diseases Drug: X-82 Drug: Anti-VEGF Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked, Placebo-Controlled, Dose- Finding, Non-Inferiority Study of X-82 Plus Prn Intravitreal (Ivt) Anti-VEGF Compared to Prn Ivt Anti-VEGF Monotherapy in Neovascular AMD

Resource links provided by NLM:


Further study details as provided by Tyrogenex:

Primary Outcome Measures:
  • Mean Change in Visual Acuity Score From Day -1 to Week52 [ Time Frame: Week 52 ]
    The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.


Estimated Enrollment: 132
Study Start Date: March 2015
Estimated Study Completion Date: January 2018
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg of X-82 plus ivt anti-VEGF prn
Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.
Drug: X-82
Other Name: X-82 tablets
Drug: Anti-VEGF
Other Names:
  • Aflibercept (Eylea)
  • Ranibizumab (Lucentis)
  • Bevacizumab (Avastin)
Experimental: 100 mg of X-82 plus ivt anti-VEGF prn
Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.
Drug: X-82
Other Name: X-82 tablets
Drug: Anti-VEGF
Other Names:
  • Aflibercept (Eylea)
  • Ranibizumab (Lucentis)
  • Bevacizumab (Avastin)
Experimental: 200 mg of X-82 plus ivt anti-VEGF prn
Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.
Drug: X-82
Other Name: X-82 tablets
Drug: Anti-VEGF
Other Names:
  • Aflibercept (Eylea)
  • Ranibizumab (Lucentis)
  • Bevacizumab (Avastin)
Placebo Comparator: Placebo plus ivt anti-VEGF prn
Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.
Drug: Anti-VEGF
Other Names:
  • Aflibercept (Eylea)
  • Ranibizumab (Lucentis)
  • Bevacizumab (Avastin)
Drug: Placebo

Detailed Description:

Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups:

  • X-82 50 mg plus ivt anti-VEGF prn
  • X-82 100 mg plus ivt anti-VEGF prn
  • X-82 200 mg plus ivt anti-VEGF prn
  • Placebo plus ivt anti-VEGF prn

Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.

Primary Efficacy Outcome:

The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization.

Safety Outcomes:

Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events.

Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).

  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:

  • Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 6 months prior to joining the study and has required at least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater than 6 weeks for the past two injections in the eye that is selected to be the study eye.
  • Must have demonstrated a reduction in macular fluid or macular thickness in the study eye 14 days following an anti-VEGF injection at Screening Visit 1
  • Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25 letters (20/320) or better in both eyes

Exclusion Criteria:

  • Previous vitrectomy to the study eye within 30 days of Screening Visit 1
  • Choroidal neovascularization (CNV) due to causes other than AMD
  • Proliferative diabetic retinopathy in either eye
  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): NCT02348359


  Show 35 Study Locations
Sponsors and Collaborators
Tyrogenex
  More Information

Responsible Party: Tyrogenex
ClinicalTrials.gov Identifier: NCT02348359     History of Changes
Other Study ID Numbers: X82-OPH-201
First Submitted: January 21, 2015
First Posted: January 28, 2015
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by Tyrogenex:
Vascular Endothelial Growth Factor (VEGF)
Platelet Derived Growth Factor (PDGF)
AMD

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Diseases
Wet Macular Degeneration
Retinal Degeneration
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents