Pilot Study of X-82 in Patients With Wet AMD

A Phase 1 Open-label, Dose Escalation Clinical Trial to Evaluate the Safety and Preliminary Biologic Activity/Efficacy of the VEGFR/PDGFR Inhibitor X-82 Administered Per Os in Subjects With Neovascular Age-related Macular Degeneration (AMD)

NCT01674569•Tyrogenex

View on ClinicalTrials.gov

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).

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Active choroidal neovascularization (CNV) associated with AMD, as evidenced on fluorescein angiography (FA) and OCT.
•2. No previous treatment with anti-VEGF therapy or prior anti-VEGF therapy with evidence of response to treatment and the need for additional treatment.
•3. Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA 20/32 to 20/320 in the study eye(s).
•4. Adequate bone marrow function.
•5. PT within the institutional upper limit of normal.
•6. Adequate hepatic function.
•7. Adequate renal function; serum creatinine.
•8. Ability to swallow oral medication.
•9. Age ≥ 50 years.
•10. Willing and able to provide written informed consent, comply with the investigational study protocol and return for all study visits.

Exclusion Criteria

•1. Previous treatment with photodynamic therapy (PDT) within 4 months of screening in the study eye.
•2. CNV due to causes other than AMD.
•3. Geographic atrophy involving the foveal center in the study eye.
•4. Any retinal vascular disease or retinal degeneration other than AMD in the study eye.
•5. In the opinion of the investigator, any significant disease in the study eye that could compromise best-corrected visual acuity.
•6. Cataract surgery in the study eye within three months of screening.
•7. Trabeculectomy or aqueous shunt or valve in the study eye.
•8. Intraocular surgery in the study eye within three months of screening; Nd:YAG capsulotomy or laser iridotomy within 30 days of screening.
•9. Inadequate pupillary dilation or significant media opacities in the study eye.
•10. Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy within thirty (30) days of baseline with the exception of subjects who are participating in the AREDS2 study.
+13 more criteria

Locations (5)

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States

New England Retina Associates

New London, Connecticut, United States

Elman Retina Group

Baltimore, Maryland, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Retina Consultants of Houston

Houston, Texas, United States

Key Dates

Start Date

October 1, 2012

Primary Completion Date

February 1, 2015

Completion Date

February 1, 2015

Last Updated

August 7, 2018

Enrollment

ACTUAL participants

Conditions

Exudative Macular Degeneration

Interventions

X-82 oral

DRUG

ranibizumab (Lucentis)

DRUG

MMP-9 Inhibition for Recalcitrant Wet AMD

NCT04504123

Exudative Macular DegenerationWet Age-related Macular Degeneration

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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