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

June 22, 2021 updated by: Santen Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Makati City, Philippines
        • Asian Eye Institute
      • Makati City, Philippines
        • Peregrine Eye and Laser Institute
      • Pasig City, Philippines
        • The Medical City
      • Quezon City, Philippines
        • St. Luke's Medical center Quezon City
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85296
        • Retina Research Institute
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Colorado
      • Golden, Colorado, United States, 80401
        • Colorado Retina Associates
    • Florida
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Retina Reseach Center
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston
      • McAllen, Texas, United States, 78503
        • Valley Retina Insititute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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