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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ClinicalTrials.gov Identifier: NCT03211234 |
Recruitment Status :
Completed
First Posted : July 7, 2017
Last Update Posted : October 5, 2020
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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) |
Actual 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 |
Actual Primary Completion Date : | December 31, 2019 |
Actual Study Completion Date : | January 31, 2020 |

Arm | Intervention/treatment |
---|---|
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. |
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. |
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. |
- 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 |
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

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
United States, Arizona | |
Retina Research Institute | |
Gilbert, Arizona, United States, 85296 | |
United States, California | |
Retina-Vitreous Associates | |
Beverly Hills, California, United States, 90211 | |
Northern California Retina Vitreous Associates | |
Mountain View, California, United States, 94040 | |
Bay Area Retina Associates | |
Walnut Creek, California, United States, 94598 | |
United States, Colorado | |
Colorado Retina Associates | |
Golden, Colorado, United States, 80401 | |
United States, Florida | |
National Ophthalmic Research Institute | |
Fort Myers, Florida, United States, 33912 | |
United States, South Dakota | |
Black Hills Regional Eye Institute | |
Rapid City, South Dakota, United States, 57701 | |
United States, Texas | |
Retina Reseach Center | |
Austin, Texas, United States, 78705 | |
Retina Consultants of Houston | |
Houston, Texas, United States, 77030 | |
Valley Retina Insititute | |
McAllen, Texas, United States, 78503 | |
Philippines | |
Asian Eye Institute | |
Makati City, Philippines | |
Peregrine Eye and Laser Institute | |
Makati City, Philippines | |
The Medical City | |
Pasig City, Philippines | |
St. Luke's Medical center Quezon City | |
Quezon City, Philippines |
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: | October 5, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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