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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03211234•Santen Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

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
+2 more criteria

Locations (14)

Retina Research Institute

Gilbert, Arizona, United States

Retina-Vitreous Associates

Beverly Hills, California, United States

Northern California Retina Vitreous Associates

Mountain View, California, United States

Bay Area Retina Associates

Walnut Creek, California, United States

Colorado Retina Associates

Golden, Colorado, United States

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Retina Reseach Center

Austin, Texas, United States

Retina Consultants of Houston

Houston, Texas, United States

Valley Retina Insititute

McAllen, Texas, United States

Key Dates

Start Date

July 5, 2017

Primary Completion Date

December 31, 2019

Completion Date

January 31, 2020

Last Updated

July 13, 2021

Enrollment

ACTUAL participants

Conditions

Age-Related Macular Degeneration

Interventions

2.0 mg DE-122 Injectable Solution + Lucentis

DRUG

4.0 mg DE-122 Injectable Solution + Lucentis

DRUG

Lucentis

DRUG

Direct Discrimination of Quantum States by the Human Eye

NCT05913063

Age-Related Macular Degeneration

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RECRUITINGPHASE2

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

NCT06990269

Geographic Atrophy Secondary to Age-related Macular Degeneration

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RECRUITINGPHASE4

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Direct Discrimination of Quantum States by the Human Eye

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)