Efficacy and Safety Study of ESBA1008 Versus EYLEA®
Condition: Exudative Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: ESBA1008 solution; Aflibercept
Intervention description: For intravitreal (IVT) injection; For intravitreal (IVT) injection
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age-Related Macular Degeneration; Wet; Exudative; AMD; Intravitreal injection; Retina

Summary:

      The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in
      the treatment of exudative age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Give written informed consent; be able to make the required study visits and follow
             instructions.

          -  Diagnosis of wet age-related macular degeneration, as specified in protocol.

          -  Best-corrected visual acuity (BCVA) as specified in protocol

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Either eye: Any active ocular or periocular infection or active intraocular
             inflammation.

          -  Study eye: Any approved or investigational treatment for exudative AMD other than
             vitamin supplements.

          -  Study eye: Any current or history of macular or retinal disease other than exudative
             AMD.

          -  Study eye: Any concurrent intraocular condition that, in the opinion of the
             Investigator, could require medical or surgical intervention during the course of the
             study to prevent or treat vision loss, or that limits the potential to gain visual
             acuity with the investigational product.

          -  Study eye: Uncontrolled glaucoma.

          -  Study eye: Any ocular disease that, in the opinion of the Investigator, could
             compromise the visual acuity.

          -  Study eye: History of eye surgery, as specified in protocol.

          -  Study eye: Use of corticosteroids, as specified in protocol.

          -  Any medical condition that, in the opinion of the Investigator, would preclude
             scheduled study visits, completion of the study or safe administration of
             investigational product.

          -  Any screening laboratory result that, in the opinion of the Investigator, would make
             the patient unsuitable for study participation.

          -  History of hypersensitivity to any component used in the study, as assessed by the
             Investigator.

          -  Women of childbearing potential: Lactating, pregnant, plan to become pregnant, or not
             using adequate birth control, as specified in protocol.

          -  Participation in an investigational drug or device study within time period specified
             in protocol.

          -  Other protocol-defined exclusion criteria may apply.