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OpenTrials
Completed

NCT Number: NCT02022540

Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD

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).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Colorado Springs, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAN-90806 Ophthalmic Solution

Drug

Other names: PAN-90806 Eye Drops

Lucentis

Drug

Other names: ranibizumab

Primary outcomes

  1. Safety

    Time frame: 3 months

    Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes

Sponsors and collaborators

Lead sponsor

PanOptica, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 27, 2013
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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