CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
X-82 oral +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01674569
NCT01674569Phase 2Completed
CompareCT.gov

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)

Tyrogenex·interventional·Posted Aug 29, 2012·Updated Aug 7, 2018

In Brief

A Phase 2 clinical trial evaluating X-82 oral and ranibizumab (Lucentis) for Exudative Macular Degeneration. Completed, enrolled 35 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExudative Macular Degeneration
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2012
Enrollment StartOct 1, 2012
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.8 years ago

Interventions

X-82 oraldrug

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

ranibizumab (Lucentis)drug

Rescue treatment with intravitreal ranibizumab (Lucentis) as needed