Palomid 529 is a dual TORC1/2 inhibitor of the PI3K/Akt/mTOR pathway having broad activity in angiogenesis and cellular proliferation. Palomid 529 will be examined to determine if the safety, tolerability and pharmacokinetic profile of single ascending doses when administered intravitreally or subconjunctivally.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
comparison of different dosages of drug
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Safety-Review AEs, concomitant meds-Vitals, HR, systolic/diastolic BP, temperature, weight-ECG changes; Physical exam-Laboratory parameters-Ophthalmic exam-visual acuity, IOP, slit lamp fundus exam, fundus photography, fluorescein angiography, OCT
Time frame: 43 days
Efficacy-Mean change in visual acuity by ETDRS testing-Decreased leakage and/or size on FA, decreased retinal thickness in OCT-Decreased fibrosis if detectable based on fundus examination, photography, angiography and OCT
Time frame: 43 days
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