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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479372
• Other study ID #: PAN-01-102
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 26, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: July 2019
• Source: PanOptica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 27, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration

Locations

Country	Name	City	State
Czechia	Axon Clinical	Praha
Czechia	Fakultní nemocnice Královské Vinohrady	Praha
Hungary	Semmelweis University	Budapest
Hungary	University of Debrecen	Debrecen
Latvia	P. Stradina Clinical University hospital	Riga
United Kingdom	Barnet Hospital	Barnet	Hertfordshire
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Moorefields Eye Hospital	London
United Kingdom	Manchester Royal Eye Hospital	Manchester
United Kingdom	New Cross Hospital	Wolverhampton	West Midlands
United States	Vision Research Center	Albuquerque	New Mexico
United States	Retina Center of New Jersey	Bloomfield	New Jersey
United States	Duke University	Durham	North Carolina
United States	Colorado Retina Associates	Golden	Colorado
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Retinal Consultants of Nevada	Henderson	Nevada
United States	Retinal Consultants of Nevada	Las Vegas	Nevada
United States	Retina Center of New Jersey	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
PanOptica, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Hungary,  Latvia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events		up to 12 weeks
Secondary	Mean change from baseline in study eye ETDRS Visual Acuity		through Week 12
Secondary	Mean change from baseline in study eye retinal thickness		through Week 12
Secondary	Number of patients needing additional treatment with ranibizumab		through Week 12