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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02348359
Other study ID # X82-OPH-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 16, 2015
Est. completion date January 12, 2018

Study information

Verified date February 2022
Source Tyrogenex
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Terminated
Enrollment 157
Est. completion date January 12, 2018
Est. primary completion date December 12, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
X-82

Anti-VEGF

Placebo


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Tyrogenex International Drug Development Institute, SynteractHCR

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in Visual Acuity Score From Day -1 to Week52 The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization. Week 52
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