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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2019

Interventions

  • Drug: DE-122 Injectable Solution + Lucentis
    • Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.
  • Drug: DE-122 Injectable Solution + Lucentis
    • Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
  • Drug: Lucentis
    • Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.

Arms, Groups and Cohorts

  • Experimental: Low Dose DE-122
    • Low Dose DE-122 and Lucentis
  • Experimental: High Dose DE-122
    • High Dose DE-122 and Lucentis
  • Sham Comparator: Sham
    • Sham and Lucentis

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Santen Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Santen Incorporated Clinical Operations, +1-415-268-9100, clinicaltrials@santen.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.