Trials / Completed
CompletedNCT01674569
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)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Tyrogenex · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2012-08-29
- Last updated
- 2018-08-07
- Results posted
- 2018-06-27
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01674569. Inclusion in this directory is not an endorsement.