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
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: 2.0 mg DE-122 Injectable Solution + Lucentis; 4.0 mg DE-122 Injectable Solution + Lucentis; Lucentis
Intervention description: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.; Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.; Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.
Intervention MeSH terms: Ranibizumab; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

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 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