Age-Related Macular Degeneration (AMD)Phase 1NCT02022540
Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
A Phase 1 study testing PAN-90806 Ophthalmic Solution and Lucentis in people with Age-Related Macular Degeneration (AMD), run by PanOptica, Inc. at 22 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration (AMD)
- What is being tested?
- PAN-90806 Ophthalmic Solution and Lucentis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 22 sitesUnited States
- Study dates
- Feb 2014to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Study site
Abilene, Texas
Study site
Ashland, Oregon
Study site
Austin, Texas
Study site
Bloomfield, New Jersey
Study site
Boston, Massachusetts
Study site
Charlotte, North Carolina
Study site
Colorado Springs, Colorado
Study site
Durham, North Carolina
Study site
Harlingen, Texas
Study site
Madison, Wisconsin
Study site
McAllen, Texas
Study site
Nashville, Tennessee
Study site
Philadelphia, Pennsylvania
Study site
Portsmouth, New Hampshire
Study site
Rapid City, South Dakota
Study site
San Antonio, Texas
Study site
Shawnee Mission, Kansas
Study site
Statesville, North Carolina
Study site
West Columbia, South Carolina
Study site
Wichita, Kansas
Study site
Willow Park, Texas
Study site
Winter Haven, Florida
About this study
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)
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).
- Conditions
- Age-Related Macular Degeneration (AMD)
- Being tested
- PAN-90806 Ophthalmic Solution, Lucentis
- Keywords
- Neovascular Age-Related Macular Degeneration, AMD, Macular Degeneration, Age-Related Macular Degeneration, wet AMD, neovascular AMD, exudative AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAN-90806 Ophthalmic SolutionDrug
Also called PAN-90806 Eye Drops
LucentisDrug
Also called ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 - Group 1 | Experimental | Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. Receives: Drug: PAN-90806 Ophthalmic Solution |
| Stage 1 - Group 2 | Experimental | Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. Receives: Drug: PAN-90806 Ophthalmic Solution |
| Stage 1- Group 3 | Experimental | Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. Receives: Drug: PAN-90806 Ophthalmic Solution |
| Stage 1- Group 4 | Experimental | Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. Receives: Drug: PAN-90806 Ophthalmic Solution |
| Stage 1 - Group 5 | Experimental | Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. Receives: Drug: PAN-90806 Ophthalmic Solution |
| Stage 2 | Experimental | 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 Receives: Drug: PAN-90806 Ophthalmic Solution; Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- PanOptica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Wax, M.D., Study director, PanOptica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022540
- Sponsor's protocol ID
- PAN-01-101
- Status last verified
- Sep 2016
- First submitted
- 20 Dec 2013
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02022540
- Acronym / sponsor ID
- PAN-01-101
- Conditions
- Age-Related Macular Degeneration (AMD)
- Keywords
- Neovascular Age-Related Macular Degeneration, AMD, Macular Degeneration, Age-Related Macular Degeneration, wet AMD, neovascular AMD, exudative AMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PanOptica, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stage 1 - Group 1 | Experimental | Drug: PAN-90806 Ophthalmic SolutionPatients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
| Stage 1 - Group 2 | Experimental | Drug: PAN-90806 Ophthalmic SolutionPatients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
| Stage 1- Group 3 | Experimental | Drug: PAN-90806 Ophthalmic SolutionPatients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
| Stage 1- Group 4 | Experimental | Drug: PAN-90806 Ophthalmic SolutionPatients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
| Stage 1 - Group 5 | Experimental | Drug: PAN-90806 Ophthalmic SolutionPatients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
| Stage 2 | Experimental | Drug: PAN-90806 Ophthalmic Solution, Drug: LucentisPatients 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- History or evidence of the following surgeries in the study eye:
- Uncontrolled hypertension despite use of antihypertensive medications
- Participation in any investigational drug or device study, systemic or ocular, within past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAN-90806 Ophthalmic SolutionAlso: PAN-90806 Eye Drops | Drug | Stage 1 - Group 1, Stage 1 - Group 2, Stage 1 - Group 5, Stage 1- Group 3, Stage 1- Group 4, Stage 2 |
| LucentisAlso: ranibizumab | Drug | Stage 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Wax, M.D. study director
PanOptica, Inc.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PAN-90806 Ophthalmic Solution and Lucentis in people with Age-Related Macular Degeneration (AMD), run by PanOptica, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.