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Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD

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ClinicalTrials.gov Identifier: NCT02022540
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
PanOptica, Inc.

Brief Summary:
The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular Age-Related Macular Degeneration (AMD).

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration (AMD) Drug: PAN-90806 Ophthalmic Solution Drug: Lucentis Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-Label, Multi-Center Trial With Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
Study Start Date : February 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stage 1 - Group 1
Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Name: PAN-90806 Eye Drops
Experimental: Stage 1 - Group 2
Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Name: PAN-90806 Eye Drops
Experimental: Stage 1- Group 3
Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Name: PAN-90806 Eye Drops
Experimental: Stage 1- Group 4
Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Name: PAN-90806 Eye Drops
Experimental: Stage 1 - Group 5
Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Name: PAN-90806 Eye Drops
Experimental: Stage 2
Patients enrolled in Stage 2 will receive an intravitreal injection of ranibizumab and then 7-9 days later begin daily dosing with PAN-90806 Ophthalmic Solution for 12 weeks
Drug: PAN-90806 Ophthalmic Solution
Other Name: PAN-90806 Eye Drops
Drug: Lucentis
Other Name: ranibizumab



Primary Outcome Measures :
  1. Safety [ Time Frame: 3 months ]
    Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes



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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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:

  • No prior ocular or systemic treatment or surgery for neovascular AMD in the study eye
  • 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
    • 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
  • 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): NCT02022540


Locations
United States, Colorado
Colorado Springs, Colorado, United States
United States, Florida
Winter Haven, Florida, United States
United States, Kansas
Shawnee Mission, Kansas, United States
Wichita, Kansas, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New Hampshire
Portsmouth, New Hampshire, United States
United States, New Jersey
Bloomfield, New Jersey, United States
United States, North Carolina
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Statesville, North Carolina, United States
United States, Oregon
Ashland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
West Columbia, South Carolina, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Abilene, Texas, United States
Austin, Texas, United States
Harlingen, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
Willow Park, Texas, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
PanOptica, Inc.
Investigators
Study Director: Martin Wax, M.D. PanOptica, Inc.

Responsible Party: PanOptica, Inc.
ClinicalTrials.gov Identifier: NCT02022540     History of Changes
Other Study ID Numbers: PAN-01-101
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by PanOptica, Inc.:
Neovascular Age-Related Macular Degeneration
AMD
Macular Degeneration
Age-Related Macular Degeneration
wet AMD
neovascular AMD
exudative AMD

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions
Ranibizumab
Ophthalmic Solutions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents