Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration
Condition: Exudative Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: AL-78898A; Ranibizumab
Intervention description: Investigational treatment; Anti-vascular endothelial growth factor (VEGF) treatment
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 99.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; Intravitreal Injection; Macular Degeneration; VEGF treatment

Summary:

      The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as
      measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a
      single intravitreal injection, as compared to LUCENTIS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to give informed consent, make the required study visits and follow
             instructions;

          -  Newly diagnosed with exudative age-related macular degeneration (AMD);

          -  Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary
             to AMD (study eye);

          -  Best-corrected visual acuity (BCVA) in study eye as specified in protocol;

          -  No vision-threatening ocular condition other than AMD, in the opinion of the
             Investigator;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  History or current evidence of macular or retinal disease other than exudative AMD
             (study eye);

          -  Any evidence of fibrosis or scarring within the CNV (choroidal
             neovascularization)lesion (study eye);

          -  Any evidence of vitreous hemorrhage (study eye);

          -  History or evidence of surgery (study eye), as specified in protocol;

          -  Any active systemic infection or ocular/intraocular infection or inflammation in
             either eye;

          -  A history or current medical diagnosis of glaucoma or ocular hypertension (study eye),
             as specified in protocol;

          -  History or current evidence of a medical condition that may in the opinion of the
             Investigator preclude the safe administration of test article, adherence to the
             scheduled study visits, safe participation in the study or affect the results of the
             study

          -  History of severe or serious hypersensitivity to any component of the investigational
             product, reference product or clinically relevant sensitivity to fluorescein dye, as
             assessed by the Investigator;

          -  Females of childbearing potential may not participate in the study if pregnant,
             lactating, or not using adequate birth control methods for the duration of the study;

          -  Participation in any ocular or non-ocular investigational study within 30 days of
             screening;

          -  Has received any approved or investigational therapy for AMD in the study eye with the
             exception of vitamins;

          -  Other protocol-defined exclusion criteria may apply.