Trial record 1 of 1 for:
36-002
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
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03211234 |
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Recruitment Status :
Recruiting
First Posted : July 7, 2017
Last Update Posted : February 6, 2019
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Sponsor:
Santen Inc.
Information provided by (Responsible Party):
Santen Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Age-Related Macular Degeneration | Drug: DE-122 Injectable Solution + Lucentis Drug: Lucentis | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 76 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | July 5, 2017 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | January 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Ranibizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Low Dose DE-122
Low Dose DE-122 and Lucentis
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Drug: DE-122 Injectable Solution + Lucentis
Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis. |
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Experimental: High Dose DE-122
High Dose DE-122 and Lucentis
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Drug: DE-122 Injectable Solution + Lucentis
Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis. |
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Sham Comparator: Sham
Sham and Lucentis
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Drug: Lucentis
Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis. |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
[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
[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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211234
Contacts
| Contact: Santen Incorporated Clinical Operations | +1-415-268-9100 | clinicaltrials@santen.com |
Locations
| United States, Arizona | |
| Retina Research Institute | Recruiting |
| Gilbert, Arizona, United States, 85296 | |
| United States, California | |
| Retina-Vitreous Associates | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| Northern California Retina Vitreous Associates | Recruiting |
| Mountain View, California, United States, 94040 | |
| Bay Area Retina Associates | Recruiting |
| Walnut Creek, California, United States, 94598 | |
| United States, Colorado | |
| Colorado Retina Associates | Recruiting |
| Golden, Colorado, United States, 80401 | |
| United States, Florida | |
| National Ophthalmic Research Institute | Recruiting |
| Fort Myers, Florida, United States, 33912 | |
| United States, South Dakota | |
| Black Hills Regional Eye Institute | Recruiting |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Texas | |
| Retina Reseach Center | Recruiting |
| Austin, Texas, United States, 78705 | |
| Retina Consultants of Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Valley Retina Insititute | Recruiting |
| McAllen, Texas, United States, 78503 | |
| Philippines | |
| Asian Eye Institute | Active, not recruiting |
| Makati City, Philippines | |
| Peregrine Eye and Laser Institute | Active, not recruiting |
| Makati City, Philippines | |
| The Medical City | Active, not recruiting |
| Pasig City, Philippines | |
| St. Luke's Medical center Quezon City | Active, not recruiting |
| Quezon City, Philippines | |
Sponsors and Collaborators
Santen Inc.
| Responsible Party: | Santen Inc. |
| ClinicalTrials.gov Identifier: | NCT03211234 |
| Other Study ID Numbers: |
36-002 |
| First Posted: | July 7, 2017 Key Record Dates |
| Last Update Posted: | February 6, 2019 |
| Last Verified: | February 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab Pharmaceutical Solutions |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |