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

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ClinicalTrials.gov Identifier: NCT03479372
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
PanOptica, Inc.

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.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: PAN-90806 Ophthalmic Suspension Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking will be maintained by using a coded drug supply.
Primary Purpose: Treatment
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)
Actual Study Start Date : April 26, 2018
Actual Primary Completion Date : May 27, 2019
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: PAN-90806 Eye Drops




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline in study eye ETDRS Visual Acuity [ Time Frame: through Week 12 ]
  2. Mean change from baseline in study eye retinal thickness [ Time Frame: through Week 12 ]
  3. Number of patients needing additional treatment with ranibizumab [ Time Frame: through Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479372


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

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Responsible Party: PanOptica, Inc.
ClinicalTrials.gov Identifier: NCT03479372     History of Changes
Other Study ID Numbers: PAN-01-102
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PanOptica, Inc.:
AMD
wet AMD
exudative AMD
macular degeneration

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions