Age-Related Macular DegenerationPhase 2VAPOR1NCT02401945
A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration
A Phase 2 study testing DE-120 and Aflibercept in people with Age-Related Macular Degeneration, run by Santen Inc. at 14 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT) administration of DE-120 in subjects with treatment-naive active subfoveal choroidal neovascularization (CNV) secondary to 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?
- DE-120 and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 14 sitesUnited States
- Study dates
- Apr 2015to 31 Oct 2016
- Phase
- Phase 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
- Provide signed written informed consent
- Diagnosis of active CNV secondary to wet AMD, with some subfoveal component in the study eye
- No evidence of subfoveal fibrosis or subfoveal RPE atrophy in the study eye
- At least one lesion in the study eye that meets minimal pathology criteria
- Best corrected visual acuity of 70 to 25 ETDRS letters in the study eye
- Best corrected visual acuity of 20/320 or better in the fellow eye
- Reasonably clear media and some fixation in the study eye
Who cannot join
- Ocular
- Aphakic or has an anterior chamber intraocular lens in the study eye
- Received prior treatment with anti-VEGF, intravitreal corticosteroids or photodynamic therapy in the study eye
- Uncontrolled glaucoma despite anti-glaucoma therapy in the study eye
- Evidence of any ocular disease other than AMD in the study eye that may confound the outcome of the study
- History of vitrectomy in the study eye
Show all 14Show fewer
- Need for ocular surgery in the study eye 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
- 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
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Altamonte Springs, Florida
Study site
Bakersfield, California
Study site
Charlotte, North Carolina
Study site
Dallas, Texas
Study site
Fort Myers, Florida
Study site
Golden, Colorado
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
McAllen, Texas
Study site
Phoenix, Arizona
Study site
Portsmouth, New Hampshire
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Walnut Creek, California
About this study
Official title: A Multicenter, Randomized, Open Label, Phase IIa Study Assessing the Efficacy, Safety and Duration of Effect of Intravitreal Injections of DE-120 as Monotherapy and With a Single Eylea® Injection in Subjects With Treatment-Naive Exudative Age-Related Macular Degeneration
The purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT) administration of DE-120 in subjects with treatment-naive active subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- DE-120, Aflibercept
- 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
AfliberceptDrug
Also called Eylea®
| Study group | Role | What they receive |
|---|---|---|
| DE-120 Monotherapy | Experimental | DE-120 intravitreal injection given as monotherapy on a PRN basis Receives: Drug: DE-120 |
| Eylea® and DE-120 Concomitant Therapy | Experimental | DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy. Receives: Drug: DE-120; Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in BCVA at Month 8
Measured: Month 8
Secondary outcomes (3)
Change from baseline in total lesion area at Month 8
Measured: Month 8
Change from baseline in greatest linear dimension of the area of leakage at Month 8
Measured: Month 8
Change in Central Subfield Thickness at Month 8
Measured: Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startApr 2015
- Primary completion22 Jun 2016
- Study completion31 Oct 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT02401945
- Sponsor's protocol ID
- 35-002
- Acronym
- VAPOR1
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2015
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 Multicenter, Randomized, Open Label, Phase IIa Study Assessing the Efficacy, Safety and Duration of Effect of Intravitreal Injections of DE-120 as Monotherapy and With a Single Eylea® Injection in Subjects With Treatment-Naive Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02401945
- Acronym / sponsor ID
- VAPOR1 / 35-002
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- 22 Jun 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 30 Mar 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 purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT) administration of DE-120 in subjects with treatment-naive active subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DE-120 Monotherapy | Experimental | Drug: DE-120DE-120 intravitreal injection given as monotherapy on a PRN basis |
| Eylea® and DE-120 Concomitant Therapy | Experimental | Drug: DE-120, Drug: AfliberceptDE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy. |
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 active CNV secondary to wet AMD, with some subfoveal component in the study eye
- No evidence of subfoveal fibrosis or subfoveal RPE atrophy in the study eye
- At least one lesion in the study eye that meets minimal pathology criteria
- Best corrected visual acuity of 70 to 25 ETDRS letters in the study eye
Key exclusion criteria (14 listed)
- Ocular
- Aphakic or has an anterior chamber intraocular lens in the study eye
- Received prior treatment with anti-VEGF, intravitreal corticosteroids or photodynamic therapy in the study eye
- Uncontrolled glaucoma despite anti-glaucoma therapy in the study eye
- Evidence of any ocular disease other than AMD in the study eye that may confound the outcome 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 |
|---|---|---|
| DE-120 | Drug | DE-120 Monotherapy, Eylea® and DE-120 Concomitant Therapy |
| AfliberceptAlso: Eylea® | Drug | Eylea® and DE-120 Concomitant Therapy |
Primary outcome
Mean change from baseline in BCVA at Month 8
Time frame: Month 8
3 secondary outcomes
Change from baseline in total lesion area at Month 8
Time frame: Month 8
Change from baseline in greatest linear dimension of the area of leakage at Month 8
Time frame: Month 8
Change in Central Subfield Thickness at Month 8
Time frame: Month 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 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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DE-120 and Aflibercept in people with Age-Related Macular Degeneration, run by Santen Inc. at 14 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 14 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 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 14 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 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?
Mean change from baseline in BCVA at Month 8 (time frame: Month 8). 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.