Neovascular Age-related Macular DegenerationPhase 1/2NCT03479372
Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
A Phase 1/2 study testing PAN-90806 Ophthalmic Suspension in people with Neovascular Age-related Macular Degeneration, run by PanOptica, Inc. at 18 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- PAN-90806 Ophthalmic Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 26 Apr 2018to 27 Jun 2019
- Phase
- Phase 1/2
- 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
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States8 sites
Vision Research Center
Albuquerque, New Mexico, 87109
Retina Center of New Jersey
Bloomfield, New Jersey, 07003
Duke University
Durham, North Carolina, 27710
Colorado Retina Associates
Golden, Colorado, 80401
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Retinal Consultants of Nevada
Henderson, Nevada, 89052
Retinal Consultants of Nevada
Las Vegas, Nevada, 89144
Retina Center of New Jersey
Teaneck, New Jersey, 07666
United Kingdom5 sites
Barnet Hospital
Barnet, Hertfordshire, EN5 3DJ
Bradford Royal Infirmary
Bradford, BD9 6RJ
Moorefields Eye Hospital
London, EC1V 2PD
Manchester Royal Eye Hospital
Manchester, M13 9WL
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP
Czechia2 sites
Fakultní nemocnice Královské Vinohrady
Prague, 100 34
Axon Clinical
Prague, 150 00
Hungary2 sites
Semmelweis University
Budapest, 1085
University of Debrecen
Debrecen, 4032
About this study
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)
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.
Read the 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.
- Being tested
- PAN-90806 Ophthalmic Suspension
- Keywords
- AMD, wet AMD, exudative AMD, macular degeneration
- 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 SuspensionDrug
Also called PAN-90806 Eye Drops
PAN-90806 provided in single-use dropper bottles for topical ocular administration
| Study group | Role | What they receive |
|---|---|---|
| PAN-90806 Eye Drops, dose 1 | Experimental | PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks Receives: Drug: PAN-90806 Ophthalmic Suspension |
| PAN-90806 Eye Drops, dose 2 | Experimental | PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks Receives: Drug: PAN-90806 Ophthalmic Suspension |
| PAN-90806 Eye Drops, dose 3 | Experimental | PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks Receives: Drug: PAN-90806 Ophthalmic Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
Measured: up to 12 weeks
Secondary outcomes (3)
Mean change from baseline in study eye ETDRS Visual Acuity
Measured: through Week 12
Mean change from baseline in study eye retinal thickness
Measured: through Week 12
Number of patients needing additional treatment with ranibizumab
Measured: through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start26 Apr 2018
- Primary completion27 May 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- PanOptica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Wax, MD, Study director, PanOptica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479372
- Sponsor's protocol ID
- PAN-01-102
- Status last verified
- Jul 2019
- First submitted
- 14 Mar 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03479372
- Acronym / sponsor ID
- PAN-01-102
- Keywords
- AMD, wet AMD, exudative AMD, macular degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- PanOptica, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 27 Mar 2018 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAN-90806 Eye Drops, dose 1 | Experimental | Drug: PAN-90806 Ophthalmic SuspensionPAN-90806 Ophthalmic Suspension taken once daily for 12 weeks |
| PAN-90806 Eye Drops, dose 2 | Experimental | Drug: PAN-90806 Ophthalmic SuspensionPAN-90806 Ophthalmic Suspension taken once daily for 12 weeks |
| PAN-90806 Eye Drops, dose 3 | Experimental | Drug: PAN-90806 Ophthalmic SuspensionPAN-90806 Ophthalmic Suspension taken once daily 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 (10 listed)
- 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
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 SuspensionAlso: PAN-90806 Eye DropsPAN-90806 provided in single-use dropper bottles for topical ocular administration | Drug | PAN-90806 Eye Drops, dose 1, PAN-90806 Eye Drops, dose 2, PAN-90806 Eye Drops, dose 3 |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: up to 12 weeks
3 secondary outcomes
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
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 9 Jul 2019.
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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, MD study director
PanOptica, Inc.
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PAN-90806 Ophthalmic Suspension in people with Neovascular Age-related Macular Degeneration, run by PanOptica, Inc. at 18 sites in 5 countries.
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 10 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, United Kingdom, Czechia, Hungary, Latvia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of participants with treatment-related adverse events (time frame: up to 12 weeks). 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 9 Jul 2019.