Age-Related Macular DegenerationPhase 1/2NCT02022501
A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration
A Phase 1/2 study testing DE-120 in people with Age-Related Macular Degeneration, run by Santen Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability, bioactivity and pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in subjects with late stage exudative age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- DE-120
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2014to 21 Apr 2016
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Understand and provide signed written informed consent
- Diagnosis of chronic subretinal or intraretinal fluid secondary to exudative age-related macular degeneration in the study eye
- At least one lesion in the study eye that meets minimal pathology criteria
- Visual acuity of ≤ 55 ETDRS letter (20/80 Snellen equivalent) or worse in the study eye, excluding No Light Perception
- Reasonably clear media and some fixation in the study eye
Main Exclusion Criteria:
Ocular
- Visual acuity of No Light Perception
- Aphakic or has an anterior chamber intraocular lens in the study eye.
- Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1
- Uncontrolled glaucoma, chronic hypotony or vitrectomy in the study eye
- Evidence of any other ocular disease other than late stage exudative age related macular degeneration in the study eye that may confound the outcome of the study .
- Proscribed ocular surgery in the study eye either prior to or during the course of the trial
- Presence or history of certain ocular or periocular pathology or conditions that could limit ability to perform required study assessments in either eye and/or confound study results
Non-Ocular
- Systemic treatment with anti-VEGF agents (e.g., bevacizumab) is prohibited at any time during the study
- Allergy or hypersensitivity to study drug product, fluorescein dye, or other study related procedures/medications.
- Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for a clinical trial
- Participation in other investigational drug or device clinical trials within 30 days prior to Screening or planning to participate in other investigational drug or device clinical trials for the duration of the study
- Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study
- Unable to comply with study procedures or follow-up visits
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Bakersfield, California
Study site
Beverly Hills, California
Study site
Dallas, Texas
About this study
Official title: A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Pharmacokinetics and Bioactivity of a Single Intravitreal Injection of DE-120 Injectable Solution for the Treatment of Late Stage Exudative Age-related Macular Degeneration
The purpose of this study is to assess the safety, tolerability, bioactivity and pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in subjects with late stage exudative age-related macular degeneration.
Read the detailed description
This is an open-label, dose-escalating, sequential-cohort study of DE-120 injectable solution administered in 9, and up to 12, subjects with late stage exudative age-related macular degeneration.
Three cohorts of 3 subjects will receive a single intravitreal injection in the study eye. Subjects in Cohort 1 will receive a single intravitreal injection of Low Dose DE-120 injectable solution in the study eye and will be evaluated through Visit 5 (Month 1). If the Low Dose is considered to be safe, the next higher dose will be administered to Cohort 2.
The same enrollment and safety review procedures will be followed for Cohort 2 (Medium Dose DE-120) and Cohort 3 (High Dose DE-120).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- DE-120
- Keywords
- 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.
DE-120Drug
| Study group | Role | What they receive |
|---|---|---|
| Low Dose DE-120 | Experimental | Single 20 µL intravitreal injection of Low Dose DE-120 injectable solution Receives: Drug: DE-120 |
| Medium Dose DE-120 | Experimental | Single 20 µL intravitreal injection of Medium Dose DE-120 injectable solution Receives: Drug: DE-120 |
| High Dose DE-120 | Experimental | Single 20 µL intravitreal injection of High Dose DE-120 injectable solution Receives: Drug: DE-120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Adverse events will be assessed at each visit to assess safety
Measured: Each visit from Day 1 to Study Exit (Month 24)
Change from Baseline in central subfield thickness (CST)
CST will be measured using spectral domain optical coherence tomography (SD-OCT)
Measured: Each visit from Day 1 through Study Exit (Month 24)
Change from Baseline in macular volume
Macular volume will be measured using spectral domain optical coherence tomography (SD-OCT)
Measured: Each visit from Day 1 through Study Exit (Month 24)
Drug concentration in plasma over time after a single injection of DE-120
Pharmacokinetic assessments will include area under the plasma concentration time curve (AUC), peak plasma concentration (Cmax), time to peak plasma concentration (tmax) and elimination half life (t1/2)
Measured: Most visits from Day 1 through Study Exit (Month 24)
Secondary outcomes (1)
Change from Baseline in ocular signs and symptoms
Ocular signs and ocular symptoms will be collected at each visit using slit lamp biomicroscopy, corrected visual acuity, ophthalmoscopy and intraocular pressure measurements
Measured: Each visit from Day 1 through Study Exit (Month 24)
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 startJan 2014
- Primary completion21 Apr 2016
- Study completion21 Apr 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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022501
- Sponsor's protocol ID
- 35-001
- Status last verified
- Apr 2018
- First submitted
- 20 Dec 2013
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Pharmacokinetics and Bioactivity of a Single Intravitreal Injection of DE-120 Injectable Solution for the Treatment of Late Stage Exudative Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02022501
- Acronym / sponsor ID
- 35-001
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- 21 Apr 2016 (actual)
- Study completion
- 21 Apr 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 purpose of this study is to assess the safety, tolerability, bioactivity and pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in subjects with late stage exudative age-related macular degeneration.
Detailed description
This is an open-label, dose-escalating, sequential-cohort study of DE-120 injectable solution administered in 9, and up to 12, subjects with late stage exudative age-related macular degeneration.
Three cohorts of 3 subjects will receive a single intravitreal injection in the study eye. Subjects in Cohort 1 will receive a single intravitreal injection of Low Dose DE-120 injectable solution in the study eye and will be evaluated through Visit 5 (Month 1). If the Low Dose is considered to be safe, the next higher dose will be administered to Cohort 2.
The same enrollment and safety review procedures will be followed for Cohort 2 (Medium Dose DE-120) and Cohort 3 (High Dose DE-120).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose DE-120 | Experimental | Drug: DE-120Single 20 µL intravitreal injection of Low Dose DE-120 injectable solution |
| Medium Dose DE-120 | Experimental | Drug: DE-120Single 20 µL intravitreal injection of Medium Dose DE-120 injectable solution |
| High Dose DE-120 | Experimental | Drug: DE-120Single 20 µL intravitreal injection of High Dose DE-120 injectable solution |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| DE-120 | Drug | High Dose DE-120, Low Dose DE-120, Medium Dose DE-120 |
Primary outcome
Number of subjects with adverse events
Time frame: Each visit from Day 1 to Study Exit (Month 24)
Adverse events will be assessed at each visit to assess safety
Change from Baseline in central subfield thickness (CST)
Time frame: Each visit from Day 1 through Study Exit (Month 24)
CST will be measured using spectral domain optical coherence tomography (SD-OCT)
Change from Baseline in macular volume
Time frame: Each visit from Day 1 through Study Exit (Month 24)
Macular volume will be measured using spectral domain optical coherence tomography (SD-OCT)
Drug concentration in plasma over time after a single injection of DE-120
Time frame: Most visits from Day 1 through Study Exit (Month 24)
Pharmacokinetic assessments will include area under the plasma concentration time curve (AUC), peak plasma concentration (Cmax), time to peak plasma concentration (tmax) and elimination half life (t1/2)
1 secondary outcome
Change from Baseline in ocular signs and symptoms
Time frame: Each visit from Day 1 through Study Exit (Month 24)
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 18 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DE-120 in people with Age-Related Macular Degeneration, run by Santen Inc. at 3 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?
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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 subjects with adverse events (time frame: Each visit from Day 1 to Study Exit (Month 24)). The study lists 4 primary outcomes in all. 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 18 Apr 2018.