Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD

July 8, 2019 updated by: PanOptica, Inc.

A Randomized, Double Masked, Uncontrolled , Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN-90806 Eye Drops, Suspension in Treatment-Naïve Participants With Neovascular Age-Related Macular Degeneration (AMD)

Double-masked, uncontrolled, multi-center, study in which participants will be randomized to one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with newly diagnosed, active, pathologic CNV associated with neovascular AMD will be screened for inclusion into the study after providing written informed consent. Participants who are eligible for the study will be centrally randomized at Day 1 to one of three doses of PAN-90806 Eye Drops. Participants will be instructed to apply one drop of PAN-90806 to the ocular surface of the identified study eye once daily for twelve (12) weeks.

Participants will return for follow-up visits at Week 2, Week 4, Week 8, Week 12, 1 week after stopping PAN-90806 treatment and 1 month after stopping PAN-90806 treatment.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2
  • 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

  • Czechia
      • Praha, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha, Czechia, 150 00
        • AXON Clinical
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis University
      • Debrecen, Hungary, 4032
        • University of Debrecen
  • Latvia
      • Riga, Latvia, LV1002
        • P. Stradina Clinical University Hospital
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • London, United Kingdom, EC1V 2PD
        • Moorefields Eye Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Eye Hospital
    • Hertfordshire
      • Barnet, Hertfordshire, United Kingdom, EN5 3DJ
        • Barnet Hospital
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • New Cross Hospital
  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Colorado Retina Associates
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Retinal Consultants of Nevada
      • Las Vegas, Nevada, United States, 89144
        • Retinal Consultants of Nevada
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Retina Center of New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Retina Center of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Vision Research Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

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

48 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:

  • Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye
  • Prior use within the last 3 months or a high possibility of requiring treatment with anti-VEGF therapy in the fellow eye during the study
  • Significant retinal serous pigment epithelial detachment (PED), atrophy, or fibrosis/scar involving the fovea
  • 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, and/or 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
  • Women of child-bearing potential who are not using a highly effective form of birth control
  • 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAN-90806 Eye Drops, dose 1
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
Drug: PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Other Names:
  • PAN-90806 Eye Drops
Experimental: PAN-90806 Eye Drops, dose 2
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
Drug: PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Other Names:
  • PAN-90806 Eye Drops
Experimental: PAN-90806 Eye Drops, dose 3
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
Drug: PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Other Names:
  • PAN-90806 Eye Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events
Time Frame: up to 12 weeks
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in study eye ETDRS Visual Acuity
Time Frame: through Week 12
through Week 12
Mean change from baseline in study eye retinal thickness
Time Frame: through Week 12
through Week 12
Number of patients needing additional treatment with ranibizumab
Time Frame: through Week 12
through Week 12

Collaborators and Investigators

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

Sponsor

PanOptica, Inc.

Investigators

  • Study Director: Martin Wax, MD, 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 (Actual)

April 26, 2018

Primary Completion (Actual)

May 27, 2019

Study Completion (Actual)

June 27, 2019

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN-01-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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