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

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.

Completed

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asian Eye Institute, Makati City, Philippines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2.0 mg DE-122 Injectable Solution + Lucentis

Drug

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

Drug

Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.

Lucentis

Drug

Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2020
First posted: Jul 7, 2017
Registry last updated: Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed