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

September 27, 2016 updated by: PanOptica, Inc.

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • Winter Haven, Florida, United States
    • Kansas
      • Shawnee Mission, Kansas, United States
      • Wichita, Kansas, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • New Hampshire
      • Portsmouth, New Hampshire, United States
    • New Jersey
      • Bloomfield, New Jersey, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Statesville, North Carolina, United States
    • Oregon
      • Ashland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • West Columbia, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Abilene, Texas, United States
      • Austin, Texas, United States
      • Harlingen, Texas, United States
      • McAllen, Texas, United States
      • San Antonio, Texas, United States
      • Willow Park, Texas, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stage 1 - Group 1
Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Names:
  • PAN-90806 Eye Drops
Experimental: Stage 1 - Group 2
Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Names:
  • PAN-90806 Eye Drops
Experimental: Stage 1- Group 3
Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Names:
  • PAN-90806 Eye Drops
Experimental: Stage 1- Group 4
Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Names:
  • PAN-90806 Eye Drops
Experimental: Stage 1 - Group 5
Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Names:
  • PAN-90806 Eye Drops
Experimental: Stage 2
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
Drug: PAN-90806 Ophthalmic Solution
Other Names:
  • PAN-90806 Eye Drops
Drug: Lucentis
Other Names:
  • ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PanOptica, Inc.

Investigators

  • Study Director: Martin Wax, M.D., PanOptica, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN-01-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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