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Trial record 1 of 2 for:    36-002
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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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211234
Recruitment Status : Completed
First Posted : July 7, 2017
Results First Posted : July 13, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Study Description
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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: 2.0 mg DE-122 Injectable Solution + Lucentis Drug: 4.0 mg DE-122 Injectable Solution + Lucentis Drug: Lucentis Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 2.0 mg DE-122
2.0 mg DE-122 and Lucentis ® 0.5 mg
 Drug: 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.
Experimental: 4.0 mg DE-122
4.0 mg DE-122 and Lucentis ® 0.5 mg
 Drug: 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 Comparator: Sham
Sham and Lucentis ® 0.5 mg
 Drug: Lucentis
Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Contacts and Locations
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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


Locations
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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
Sponsors and Collaborators
Santen Inc.
  Study Documents (Full-Text)

Documents provided by Santen Inc.:
Study Protocol  [PDF] January 8, 2019
Statistical Analysis Plan  [PDF] October 11, 2019

More Information
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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT03211234    
Other Study ID Numbers: 36-002
First Posted: July 7, 2017    Key Record Dates
Results First Posted: July 13, 2021
Last Update Posted: July 13, 2021
Last Verified: June 2021

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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