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

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PAN-90806 Ophthalmic Suspension
Sponsored by
PanOptica, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring AMD, wet AMD, exudative AMD, macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Colorado Retina Associates
  • Cumberland Valley Retina Consultants
  • Retinal Consultants of Nevada
  • Retinal Consultants of Nevada
  • Retina Center of New Jersey
  • Retina Center of New Jersey
  • Vision Research Center
  • Duke University
  • Fakultní nemocnice Královské Vinohrady
  • Axon Clinical
  • Semmelweis University
  • University of Debrecen
  • P. Stradina Clinical University hospital
  • Barnet Hospital
  • New Cross Hospital
  • Bradford Royal Infirmary
  • Moorefields Eye Hospital
  • Manchester Royal Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PAN-90806 Eye Drops, dose 1

PAN-90806 Eye Drops, dose 2

PAN-90806 Eye Drops, dose 3

Arm Description

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events

Secondary Outcome Measures

Mean change from baseline in study eye ETDRS Visual Acuity
Mean change from baseline in study eye retinal thickness
Number of patients needing additional treatment with ranibizumab

Full Information

First Posted
March 14, 2018
Last Updated
July 8, 2019
Sponsor
PanOptica, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03479372
Brief Title
Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
May 27, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PanOptica, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
AMD, wet AMD, exudative AMD, macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Masking will be maintained by using a coded drug supply.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAN-90806 Eye Drops, dose 1
Arm Type
Experimental
Arm Description
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
Arm Title
PAN-90806 Eye Drops, dose 2
Arm Type
Experimental
Arm Description
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
Arm Title
PAN-90806 Eye Drops, dose 3
Arm Type
Experimental
Arm Description
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
PAN-90806 Ophthalmic Suspension
Other Intervention Name(s)
PAN-90806 Eye Drops
Intervention Description
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline in study eye ETDRS Visual Acuity
Time Frame
through Week 12
Title
Mean change from baseline in study eye retinal thickness
Time Frame
through Week 12
Title
Number of patients needing additional treatment with ranibizumab
Time Frame
through Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Wax, MD
Organizational Affiliation
PanOptica, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Retinal Consultants of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Retinal Consultants of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Retina Center of New Jersey
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Retina Center of New Jersey
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Vision Research Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Fakultní nemocnice Královské Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Axon Clinical
City
Praha
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
P. Stradina Clinical University hospital
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Barnet Hospital
City
Barnet
State/Province
Hertfordshire
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Moorefields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Manchester Royal Eye Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

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

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