Pilot Study of X-82 in Patients With Wet AMD

Phase 1/2 Completed 35 enrolled Tyrogenex

Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2012-10
Primary completion: 2015-02
Completion: 2015-02

Publications

Results Jackson TL, Boyer D, Brown DM, Chaudhry N, Elman M, Liang C, O'Shaughnessy D, Parsons EC, Patel S, Slakter JS, Rosenfeld PJ. Oral Tyrosine Kinase Inhibitor for Neovascular Age-Related Macular Degeneration: A Phase 1 Dose-Escalation Study. JAMA Ophthalmol. 2017 Jul 1;135(7):761-767. doi: 10.1001/jamaophthalmol.2017.1571.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CM082	Unknown	50 mg	Oral
Subject	CM082	Unknown	100 mg	Oral
Subject	CM082	Unknown	200 mg	Oral
Subject	CM082	Unknown	300 mg	Oral
Background	Ranibizumab	Monoclonal antibody	—	Intravitreal

Pilot Study of X-82 in Patients With Wet AMD

Summary

Timeline

Publications

Drugs

Indications