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
NCT ID: NCT03211234
Last Updated: 2021-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2017-07-05
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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2.0 mg DE-122
2.0 mg DE-122 and Lucentis ® 0.5 mg
2.0 mg 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.
4.0 mg DE-122
4.0 mg DE-122 and Lucentis ® 0.5 mg
4.0 mg 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
Sham and Lucentis ® 0.5 mg
Lucentis
Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.
Interventions
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2.0 mg 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.
4.0 mg 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.
Lucentis
Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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Retina Research Institute
Gilbert, Arizona, United States
Retina-Vitreous Associates
Beverly Hills, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Colorado Retina Associates
Golden, Colorado, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Retina Reseach Center
Austin, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Valley Retina Insititute
McAllen, Texas, United States
Asian Eye Institute
Makati City, , Philippines
Peregrine Eye and Laser Institute
Makati City, , Philippines
The Medical City
Pasig, , Philippines
St. Luke's Medical center Quezon City
Quezon City, , Philippines
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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36-002
Identifier Type: -
Identifier Source: org_study_id
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