Age-Related Macular DegenerationPhase 1/2PAVENCT02555306
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
A Phase 1/2 study testing 0.5 mg of DE-122, 1.0 mg of DE-122 and 2.0 mg of DE-122 in people with Age-Related Macular Degeneration, run by Santen Inc. at 5 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative 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
- What is being tested?
- 0.5 mg of DE-122, 1.0 mg of DE-122 and 2.0 mg of DE-122
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Sep 2015to Aug 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provide signed written informed consent
- Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration
- Prior treatment in the study eye with any intravitreal anti-VEGF medication
- At least one lesion in the study eye that meets minimal pathology criteria
- Best corrected visual acuity of 65 to 20 ETDRS letters in the study eye
- Best corrected visual acuity of 20/200 or better in the fellow eye
- Reasonably clear media and some fixation in the study eye
Who cannot join
- Ocular
- 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 or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
- Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
- Need for ocular surgery in the study eye during the course of the study
- Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform required study assessments in either eye and/or confound study results
Show all 12Show fewer
- Non-Ocular
- Allergy or hypersensitivity to study drug product, fluorescein dye or other study-related procedures and medications
- Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study
- Participation in other investigational drug or device clinical trials within 30 days prior to randomization 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Austin, Texas, 78705
Study site
Jackson, Michigan, 49202
Study site
McAllen, Texas, 78503
Study site
Mountain View, California, 94040
Study site
Walnut Creek, California, 94598
About this study
Official title: A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration
The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- 0.5 mg of DE-122, 1.0 mg of DE-122, 2.0 mg of DE-122, 4.0 mg of DE-122
- 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.
0.5 mg of DE-122Drug
DE-122 Injectable Solution
1.0 mg of DE-122Drug
DE-122 Injectable Solution
2.0 mg of DE-122Drug
DE-122 Injectable Solution
4.0 mg of DE-122Drug
DE-122 Injectable Solution
| Study group | Role | What they receive |
|---|---|---|
| Low Dose DE-122 | Experimental | Single intravitreal injection of DE-122 Low Dose Injectable Solution Receives: Drug: 0.5 mg of DE-122 |
| Medium-Low Dose DE-122 | Experimental | Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution Receives: Drug: 1.0 mg of DE-122 |
| Medium-High Dose DE-122 | Experimental | Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution Receives: Drug: 2.0 mg of DE-122 |
| High Dose DE-122 | Experimental | Single intravitreal injection of DE-122 High Dose Injectable Solution Receives: Drug: 4.0 mg of DE-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.
BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of [0, 97] in ETDRS letters.
An increase in BCVA indicates an improvement in the best corrected vision.
Measured: Baseline (Day1) and Day 90.
Secondary outcomes (1)
Change From Baseline in Central Subfield Thickness (CST) at Day 90.
Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.
Measured: Baseline (Day1) and Day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study start16 Sep 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 12 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
- NCT02555306
- Sponsor's protocol ID
- 36-001
- Acronym
- PAVE
- Status last verified
- Jan 2020
- First submitted
- 13 Sep 2015
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. 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, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02555306
- Acronym / sponsor ID
- PAVE / 36-001
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Posted 14 Jan 2020
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 the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose DE-122 | Experimental | Drug: 0.5 mg of DE-122Single intravitreal injection of DE-122 Low Dose Injectable Solution |
| Medium-Low Dose DE-122 | Experimental | Drug: 1.0 mg of DE-122Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution |
| Medium-High Dose DE-122 | Experimental | Drug: 2.0 mg of DE-122Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution |
| High Dose DE-122 | Experimental | Drug: 4.0 mg of DE-122Single intravitreal injection of DE-122 High Dose Injectable Solution |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide signed written informed consent
- Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration
- Prior treatment in the study eye with any intravitreal anti-VEGF medication
- At least one lesion in the study eye that meets minimal pathology criteria
- Best corrected visual acuity of 65 to 20 ETDRS letters in the study eye
Key exclusion criteria (12 listed)
- Ocular
- 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 or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
- Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
- Need for ocular surgery in the study eye during the course of the study
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 |
|---|---|---|
| 0.5 mg of DE-122DE-122 Injectable Solution | Drug | Low Dose DE-122 |
| 1.0 mg of DE-122DE-122 Injectable Solution | Drug | Medium-Low Dose DE-122 |
| 2.0 mg of DE-122DE-122 Injectable Solution | Drug | Medium-High Dose DE-122 |
| 4.0 mg of DE-122DE-122 Injectable Solution | Drug | High Dose DE-122 |
Primary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.
Time frame: Baseline (Day1) and Day 90.
BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of [0, 97] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision.
1 secondary outcome
Change From Baseline in Central Subfield Thickness (CST) at Day 90.
Time frame: Baseline (Day1) and Day 90.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
5 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 0.5 mg of DE-122, 1.0 mg of DE-122 and 2.0 mg of DE-122 in people with Age-Related Macular Degeneration, run by Santen Inc. at 5 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 7 inclusion and 12 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 14 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90. (time frame: Baseline (Day1) and Day 90.). 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 14 Jan 2020.