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Pilot Study of X-82 in Patients With Wet AMD

NCT01674569 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2018-08-07

Study results available
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Summary

The objective of this study is to evaluate the safety and preliminary biologic activity/efficacy of X-82 in patients with wet Age-related Macular Degeneration (AMD). Preliminary efficacy will be assessed by change from baseline in visual acuity, fluorescein leakage, retinal thickness and fibrosis, if detectable, based on fundus examination, fundus photography, fluorescein angiography and optical coherence tomography (OCT).

Conditions

  • Exudative Macular Degeneration

Interventions

DRUG

X-82 oral

X-82 oral for 24 weeks or until unacceptable toxicity develops

DRUG

ranibizumab (Lucentis)

Rescue treatment with intravitreal ranibizumab (Lucentis) as needed

Sponsors & Collaborators

  • Tyrogenex

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674569 on ClinicalTrials.gov