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

Santen

Status and phase: Completed; Phase 2

Conditions: Age-Related Macular Degeneration

Treatments: Drug: 4.0 mg DE-122 Injectable Solution + Lucentis; Drug: 2.0 mg DE-122 Injectable Solution + Lucentis; Drug: Lucentis

Study type: Interventional

Funder types: Industry

Identifiers

NCT03211234

36-002

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 3 patient groups

2.0 mg DE-122

Experimental group

Description:

2.0 mg DE-122 and Lucentis ® 0.5 mg

Treatment:

Drug: 2.0 mg DE-122 Injectable Solution + Lucentis

4.0 mg DE-122

Experimental group

Description:

4.0 mg DE-122 and Lucentis ® 0.5 mg

Treatment:

Drug: 4.0 mg DE-122 Injectable Solution + Lucentis

Sham

Sham Comparator group

Description:

Sham and Lucentis ® 0.5 mg

Treatment:

Drug: Lucentis