Diabetic RetinopathyPhase 1NCT02475109
Study of Topical Ocular PAN-90806 in PDR
A Phase 1 study testing PAN-90806 Ophthalmic Solution in people with Diabetic Retinopathy, run by PanOptica, Inc. at 2 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 proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- PAN-90806 Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older with type 1 or type 2 diabetes
- Proliferative diabetic retinopathy (PDR) in study eye retina with or without diabetic macular edema (DME) involving the center of the macula
- 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
- Current or recent use (within the last 3 months) of anti-vascular endothelial growth factors (anti-VEGF) in either eye;
- Uncontrolled hypertension despite use of antihypertensive medications
- Unwillingness to refrain from wearing contact lenses for the duration of the study.
- 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
2 sites in 1 country.
United States2 sites
Valley Retina Institute
Harlingen, Texas, 78550
Valley Retina Institute
McAllen, Texas, 78503
About this study
Official title: A Phase 1 Open-Label, Single-Center Study to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Proliferative Diabetic Retinopathy (PDR)
The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with proliferative diabetic retinopathy.
- Conditions
- Diabetic Retinopathy
- Being tested
- PAN-90806 Ophthalmic Solution
- Keywords
- Proliferative Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
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
| Study group | Role | What they receive |
|---|---|---|
| PAN-90806 Ophthalmic Solution | Experimental | PAN-90806 Ophthalmic Solution taken daily for 8 weeks. Receives: Drug: PAN-90806 Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Adverse Events
Safety will be assessed based upon the incidence of all adverse events, ocular and systemic
Measured: 2 months
Secondary outcomes (4)
The mean change in best-corrected visual acuity from baseline
Measured: Week 8
Change in preretinal neovascularization
descriptive observations of the presence and extent as determined by ultra-wide field fluorescein angiography (FA) and color fundus photography (FP)
Measured: Week 4 and Week 8
The mean number of rescue treatments during the study
Measured: Week 8
Time to first rescue treatment
Measured: up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- PanOptica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor H Gonzalez, M.D., Principal investigator, Valley Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475109
- Sponsor's protocol ID
- PAN-01-201
- Status last verified
- Sep 2016
- First submitted
- 13 Jun 2015
- 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 1 Open-Label, Single-Center Study to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Proliferative Diabetic Retinopathy (PDR)
- ClinicalTrials.gov ID
- NCT02475109
- Acronym / sponsor ID
- PAN-01-201
- Conditions
- Diabetic Retinopathy
- Keywords
- Proliferative Diabetic Retinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PanOptica, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Jun 2015 (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 proliferative diabetic retinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAN-90806 Ophthalmic Solution | Experimental | Drug: PAN-90806 Ophthalmic SolutionPAN-90806 Ophthalmic Solution taken daily for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older with type 1 or type 2 diabetes
- Proliferative diabetic retinopathy (PDR) in study eye retina with or without diabetic macular edema (DME) involving the center of the macula
- 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 (6 listed)
- Current or recent use (within the last 3 months) of anti-vascular endothelial growth factors (anti-VEGF) in either eye;
- Uncontrolled hypertension despite use of antihypertensive medications
- Unwillingness to refrain from wearing contact lenses for the duration of the study.
- Participation in any investigational drug or device study, systemic or ocular, within past 3 months
- Women who are pregnant or nursing
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 | PAN-90806 Ophthalmic Solution |
Primary outcome
Number of Patients with Adverse Events
Time frame: 2 months
Safety will be assessed based upon the incidence of all adverse events, ocular and systemic
4 secondary outcomes
The mean change in best-corrected visual acuity from baseline
Time frame: Week 8
Change in preretinal neovascularization
Time frame: Week 4 and Week 8
The mean number of rescue treatments during the study
Time frame: Week 8
Time to first rescue treatment
Time frame: up to Week 8
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.
Victor H Gonzalez, M.D. principal investigator
Valley Retina Institute
2 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 in people with Diabetic Retinopathy, run by PanOptica, Inc. at 2 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 6 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 2 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?
Number of Patients with Adverse Events (time frame: 2 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.