Polypoidal Choroidal Vasculopathy
Conditions
Keywords
Polypoidal Choroidal Vasculopathy, PCV, Polypoid, oxigene, VDA, vascular disrupting agent, combretastatin, fosbretabulin
Brief summary
The primary objective of this study is to examine effects of fosbretabulin tromethamine (fosbretabulin) on PCV as reflected by a change from baseline in the number of polypoid lesions on indocyanine green angiography (ICGA).
Interventions
DRUGfosbretabulin
single dose, intravenous infusion
DRUGSaline
single dose, intravenous infusion
Sponsors
Mateon Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female age ≥21 years. * Asian race (e.g. Chinese, Japanese, Korean, Thai). * Polypoidal choroidal vasculopathy in the study eye * Presence of ≥ 1 visible polypoidal varicosity on ICGA. * Presence of a measurable branching vascular network * BCVA by ETDRS of 68 to 4 letters in the study eye. Ophthalmologic
Exclusion criteria
* Prior treatment with intravitreal or systemic anti-VEGF therapy within 60 days of enrollment. * Any other prior treatment for PCV including thermal laser photocoagulation, photodynamic therapy (i.e., verteporfin), or any investigational therapies. * Any history of prior retinal or subretinal surgery, transpupillary thermography, radiation, implantation of intravitreal drug delivery device, vitrectomy. * Any other intraocular surgery or laser treatment within 90 days or any surgeries planned during the study period. * Fibrosis involving ≥50% of the total lesion. * Presence of hemorrhage which potentially obscures \>75% of vascular pathology to be assessed by imaging procedures. * Retinal or choroidal vascular disease in study eye due to causes other than PCV, such as uveitis, trauma, or pathologic myopia. * Macular edema in either eye due to other causes, such as diabetic retinopathy. * Evidence of glaucomatous eye disease, glaucomatous visual field loss. * History of allergy to fluorescein or ICG dye. Medical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2 | from baseline to Day 2 |
| Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8 | from baseline to Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2 | baseline to Day 2 |
| Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8 | baseline to Day 8 |
| Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA) | Day 29 |
Countries
Hong Kong, Singapore, South Korea, Taiwan, United States
Outcome results
None listed