Age-Related Macular DegenerationPhase 2NCT03211234
Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects
A Phase 2 study testing 2.0 mg DE-122 Injectable Solution + Lucentis, 4.0 mg DE-122 Injectable Solution + Lucentis and Lucentis in people with Age-Related Macular Degeneration, run by Santen Inc. at 14 sites in 2 countries.
Trial summary
To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone. 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?
- 2.0 mg DE-122 Injectable Solution + Lucentis, 4.0 mg DE-122 Injectable Solution + Lucentis and Lucentis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 5 Jul 2017to 31 Jan 2020
- Phase
- Phase 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 active choroidal neovascularization secondary to wet AMD
- BCVA of 65 to 25 ETDRS letters (20/50 to 20/320) in the study eye
- BCVA of 25 ETDRS letters (20/320) or better in the fellow 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 and throughout the study
- 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 examinations
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
14 sites in 2 countries.
14 sites in 2 countries
United States10 sites
Retina Reseach Center
Austin, Texas, 78705
Retina-Vitreous Associates
Beverly Hills, California, 90211
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
Retina Research Institute
Gilbert, Arizona, 85296
Colorado Retina Associates
Golden, Colorado, 80401
Retina Consultants of Houston
Houston, Texas, 77030
Valley Retina Insititute
McAllen, Texas, 78503
Northern California Retina Vitreous Associates
Mountain View, California, 94040
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Bay Area Retina Associates
Walnut Creek, California, 94598
Philippines4 sites
Asian Eye Institute
Makati City
Peregrine Eye and Laser Institute
Makati City
The Medical City
Pasig
St. Luke's Medical center Quezon City
Quezon City
About this study
Official title: A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Wet Age-related Macular Degeneration - AVANTE Study
To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- 2.0 mg DE-122 Injectable Solution + Lucentis, 4.0 mg DE-122 Injectable Solution + Lucentis, Lucentis
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.0 mg DE-122 Injectable Solution + LucentisDrug
Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.
4.0 mg DE-122 Injectable Solution + LucentisDrug
Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
LucentisDrug
Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.
| Study group | Role | What they receive |
|---|---|---|
| 2.0 mg DE-122 | Experimental | 2.0 mg DE-122 and Lucentis ® 0.5 mg Receives: Drug: 2.0 mg DE-122 Injectable Solution + Lucentis |
| 4.0 mg DE-122 | Experimental | 4.0 mg DE-122 and Lucentis ® 0.5 mg Receives: Drug: 4.0 mg DE-122 Injectable Solution + Lucentis |
| Sham | Sham comparator | Sham and Lucentis ® 0.5 mg Receives: Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24
BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint.
An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start5 Jul 2017
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 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
- NCT03211234
- Sponsor's protocol ID
- 36-002
- Status last verified
- Jun 2021
- First submitted
- 6 Jul 2017
- Last updated
- 13 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Wet Age-related Macular Degeneration - AVANTE Study
- ClinicalTrials.gov ID
- NCT03211234
- Acronym / sponsor ID
- 36-002
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Posted 13 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2.0 mg DE-122 | Experimental | Drug: 2.0 mg DE-122 Injectable Solution + Lucentis2.0 mg DE-122 and Lucentis ® 0.5 mg |
| 4.0 mg DE-122 | Experimental | Drug: 4.0 mg DE-122 Injectable Solution + Lucentis4.0 mg DE-122 and Lucentis ® 0.5 mg |
| Sham | Sham comparator | Drug: LucentisSham and Lucentis ® 0.5 mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide signed written informed consent
- Diagnosis of active choroidal neovascularization secondary to wet AMD
- BCVA of 65 to 25 ETDRS letters (20/50 to 20/320) in the study eye
- BCVA of 25 ETDRS letters (20/320) or better in the fellow 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 and throughout the study
- 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 |
|---|---|---|
| 2.0 mg DE-122 Injectable Solution + LucentisSubjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis. | Drug | 2.0 mg DE-122 |
| 4.0 mg DE-122 Injectable Solution + LucentisSubjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis. | Drug | 4.0 mg DE-122 |
| LucentisSubjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis. | Drug | Sham |
Primary outcome
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24
Time frame: Week 24
BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint. An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- 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.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2.0 mg DE-122 Injectable Solution + Lucentis, 4.0 mg DE-122 Injectable Solution + Lucentis and Lucentis in people with Age-Related Macular Degeneration, run by Santen Inc. at 14 sites in 2 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 4 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 13 Jul 2021. 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, Philippines. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2021). 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?
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24 (time frame: Week 24). 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 13 Jul 2021.