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

NCT03479372 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PAN-01-102
• Study Type: interventional
• Target: 51
• Locations: 5 countries
• Sites: 18

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

AMD; wet AMD; exudative AMD; macular degeneration

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events

  up to 12 weeks

Secondary Outcomes (3)

• Mean change from baseline in study eye ETDRS Visual Acuity

  through Week 12

• Mean change from baseline in study eye retinal thickness

  through Week 12

• Number of patients needing additional treatment with ranibizumab

  through Week 12

Study Arms (3)

PAN-90806 Eye Drops, dose 1

EXPERIMENTAL

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Drug: PAN-90806 Ophthalmic Suspension

PAN-90806 Eye Drops, dose 2

EXPERIMENTAL

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Drug: PAN-90806 Ophthalmic Suspension

PAN-90806 Eye Drops, dose 3

EXPERIMENTAL

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Drug: PAN-90806 Ophthalmic Suspension

Interventions

PAN-90806 Ophthalmic Suspension DRUG

PAN-90806 provided in single-use dropper bottles for topical ocular administration

Also known as: PAN-90806 Eye Drops

PAN-90806 Eye Drops, dose 1; PAN-90806 Eye Drops, dose 2; PAN-90806 Eye Drops, dose 3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PanOptica, Inc.: lead

Study Sites (18)

Colorado Retina Associates

Golden, Colorado, 80401, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Retinal Consultants of Nevada

Henderson, Nevada, 89052, United States

Location

Retinal Consultants of Nevada

Las Vegas, Nevada, 89144, United States

Location

Retina Center of New Jersey

Bloomfield, New Jersey, 07003, United States

Location

Retina Center of New Jersey

Teaneck, New Jersey, 07666, United States

Location

Vision Research Center

Albuquerque, New Mexico, 87109, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Fakultní nemocnice Královské Vinohrady

Prague, 100 34, Czechia

Location

Axon Clinical

Prague, 150 00, Czechia

Location

Semmelweis University

Budapest, 1085, Hungary

Location

University of Debrecen

Debrecen, 4032, Hungary

Location

P. Stradina Clinical University hospital

Riga, LV1002, Latvia

Location

Barnet Hospital

Barnet, Hertfordshire, EN5 3DJ, United Kingdom

Location

New Cross Hospital

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Moorefields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Martin Wax, MD

  PanOptica, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will be maintained by using a coded drug supply.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 27, 2018
• Study Start: April 26, 2018
• Primary Completion: May 27, 2019
• Study Completion: June 27, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

CZ (2); LA (1); US (8); GB (5); HU (2)