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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.

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE April 26, 2018
Actual Primary Completion Date May 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Number of participants with treatment-related adverse events [ Time Frame: up to 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03479372 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • Mean change from baseline in study eye ETDRS Visual Acuity [ Time Frame: through Week 12 ]
  • Mean change from baseline in study eye retinal thickness [ Time Frame: through Week 12 ]
  • Number of patients needing additional treatment with ranibizumab [ Time Frame: through Week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Neovascular Age-related Macular Degeneration
Intervention  ICMJE Drug: PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Other Name: PAN-90806 Eye Drops
Study Arms  ICMJE
  • Experimental: PAN-90806 Eye Drops, dose 1
    PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
    Intervention: Drug: PAN-90806 Ophthalmic Suspension
  • Experimental: PAN-90806 Eye Drops, dose 2
    PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
    Intervention: Drug: PAN-90806 Ophthalmic Suspension
  • Experimental: PAN-90806 Eye Drops, dose 3
    PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
    Intervention: Drug: PAN-90806 Ophthalmic Suspension
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2019)
51
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
60
Actual Study Completion Date  ICMJE June 27, 2019
Actual Primary Completion Date May 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Hungary,   Latvia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03479372
Other Study ID Numbers  ICMJE PAN-01-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PanOptica, Inc.
Study Sponsor  ICMJE PanOptica, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Martin Wax, MD PanOptica, Inc.
PRS Account PanOptica, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP