Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
NCT ID: NCT02022540
Last Updated: 2016-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2014-02-28
2016-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
NCT03479372
Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™ in Patients With Wet AMD
NCT02543229
A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
NCT01089517
Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD
NCT02061865
ARC1905 (Anti-C5 Aptamer) Given With Lucentis 0.5 mg In People With Neovascular Age-Related Macular Degeneration
NCT00709527
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stage 1 - Group 1
Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
PAN-90806 Ophthalmic Solution
Stage 1 - Group 2
Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
PAN-90806 Ophthalmic Solution
Stage 1- Group 3
Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
PAN-90806 Ophthalmic Solution
Stage 1- Group 4
Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
PAN-90806 Ophthalmic Solution
Stage 1 - Group 5
Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
PAN-90806 Ophthalmic Solution
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
PAN-90806 Ophthalmic Solution
Lucentis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PAN-90806 Ophthalmic Solution
Lucentis
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PanOptica, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin Wax, M.D.
Role: STUDY_DIRECTOR
PanOptica, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Colorado Springs, Colorado, United States
Winter Haven, Florida, United States
Shawnee Mission, Kansas, United States
Wichita, Kansas, United States
Boston, Massachusetts, United States
Portsmouth, New Hampshire, United States
Bloomfield, New Jersey, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Statesville, North Carolina, United States
Ashland, Oregon, United States
Philadelphia, Pennsylvania, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
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
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PAN-01-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.