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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02022540

Enrollment

Registered

2013-12-27

Start date

2014-02-28

Completion date

2016-05-31

Last updated

2016-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration (AMD)

Keywords

Neovascular Age-Related Macular Degeneration, AMD, Macular Degeneration, Age-Related Macular Degeneration, wet AMD, neovascular AMD, exudative AMD

Brief summary

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).

Interventions

DRUGPAN-90806 Ophthalmic Solution

DRUGLucentis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	3 months	Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026