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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

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ClinicalTrials.gov Identifier: NCT03211234
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

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

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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

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Low Dose DE-122
Low Dose DE-122 and Lucentis
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
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
Drug: Lucentis
Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.




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.



Information from the National Library of Medicine

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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
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Contact: Santen Incorporated Clinical Operations +1-415-268-9100 clinicaltrials@santen.com

Locations
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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.

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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT03211234     History of Changes
Other Study ID Numbers: 36-002
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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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