Trial | NCT02022540  Report issue

Title

Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
A Phase I Open-Label, Multi-Center Trial With Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Neovascular Age-Related Macular Degeneration (AMD)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular Age-Related Macular Degeneration (AMD).
Study Started
Feb 28
2014
Primary Completion
Mar 31
2016
Study Completion
May 31
2016
Last Update
Sep 28
2016
Estimate

Drug PAN-90806 Ophthalmic Solution

  • Other names: PAN-90806 Eye Drops

Drug Lucentis

  • Other names: ranibizumab

Stage 1 - Group 1 Experimental

Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Stage 1 - Group 2 Experimental

Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Stage 1- Group 3 Experimental

Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Stage 1- Group 4 Experimental

Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Stage 1 - Group 5 Experimental

Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Stage 2 Experimental

Patients enrolled in Stage 2 will receive an intravitreal injection of ranibizumab and then 7-9 days later begin daily dosing with PAN-90806 Ophthalmic Solution for 12 weeks

Criteria 

Inclusion Criteria:

Diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD
Aged 50 years or older
Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye

Exclusion Criteria:

No prior ocular or systemic treatment or surgery for neovascular AMD in the study eye

History of or current clinical evidence in the study eye of:

aphakia
diabetic macular edema
any ocular inflammation or infections
pathological myopia
retinal detachment
advanced glaucoma
significant media opacity, including cataract

History or evidence of the following surgeries in the study eye:

penetrating keratoplasty or vitrectomy;
corneal transplant;
corneal or intraocular surgery within 3 months of Screening
Uncontrolled hypertension despite use of antihypertensive medications
Participation in any investigational drug or device study, systemic or ocular, within past 3 months
Women who are pregnant or nursing
Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation
No Results Posted