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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

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
2.0 mg DE-122 Injectable Solution + Lucentis
4.0 mg DE-122 Injectable Solution + Lucentis
Lucentis
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Research Institute
  • Retina-Vitreous Associates
  • Northern California Retina Vitreous Associates
  • Bay Area Retina Associates
  • Colorado Retina Associates
  • National Ophthalmic Research Institute
  • Black Hills Regional Eye Institute
  • Retina Reseach Center
  • Retina Consultants of Houston
  • Valley Retina Insititute
  • Asian Eye Institute
  • Peregrine Eye and Laser Institute
  • The Medical City
  • St. Luke's Medical center Quezon City

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

2.0 mg DE-122

4.0 mg DE-122

Sham

Arm Description

2.0 mg DE-122 and Lucentis ® 0.5 mg

4.0 mg DE-122 and Lucentis ® 0.5 mg

Sham and Lucentis ® 0.5 mg

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at 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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2017
Last Updated
June 22, 2021
Sponsor
Santen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03211234
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2.0 mg DE-122
Arm Type
Experimental
Arm Description
2.0 mg DE-122 and Lucentis ® 0.5 mg
Arm Title
4.0 mg DE-122
Arm Type
Experimental
Arm Description
4.0 mg DE-122 and Lucentis ® 0.5 mg
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham and Lucentis ® 0.5 mg
Intervention Type
Drug
Intervention Name(s)
2.0 mg DE-122 Injectable Solution + Lucentis
Intervention Description
Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.
Intervention Type
Drug
Intervention Name(s)
4.0 mg DE-122 Injectable Solution + Lucentis
Intervention Description
Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
Intervention Type
Drug
Intervention Name(s)
Lucentis
Intervention Description
Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24
Description
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.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Retina Research Institute
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85296
Country
United States
Facility Name
Retina-Vitreous Associates
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Retina Reseach Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Insititute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Asian Eye Institute
City
Makati City
Country
Philippines
Facility Name
Peregrine Eye and Laser Institute
City
Makati City
Country
Philippines
Facility Name
The Medical City
City
Pasig City
Country
Philippines
Facility Name
St. Luke's Medical center Quezon City
City
Quezon City
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

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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