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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03211234
• Date of registration: 06/07/2017
• Prospective Registration: No
• Primary sponsor: Santen Inc.
• Public 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
• Scientific 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
• Date of first enrolment: July 5, 2017
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03211234
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Philippines, United States

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Age-Related Macular Degeneration

Intervention(s)

Drug: Lucentis

Drug: DE-122 Injectable Solution + Lucentis

Primary Outcome(s)

Mean change from baseline in best corrected visual acuity (BCVA) at Week 24 [Time Frame: Week 24]

Secondary ID(s)

36-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors