A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy
Condition: Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: BI 754132
Intervention description: One single injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a study in adults with geographic atrophy, an advanced form of age-related macular
      degeneration. The purpose of this study is to find out how well different doses of BI 754132
      are tolerated.

      The participants are in the study for about 4 months. During this time, they visit the study
      site about 10 times. Participants receive 1 injection of BI 754132 directly into one of the
      eyes affected by geographic atrophy. In this study, BI 754132 is given to humans for the
      first time.

      The doctors compare how well participants tolerate the different doses of BI 754132. The
      doctors also regularly check the general health of the participants.
    

Eligibility criteria:

        Inclusion criteria:

        - Men and women with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration
        (AMD): For the SRD part, the GA lesion in the study eye must be ≥ 1.9 mm2 disc area in size
        (approximately ≥ 0.75 disc area in size); For the MD part the total GA lesion size in the
        study eye must be ≥ 7.5 mm2 (approximately ≥ 3 disc area in size)

          -  Fellow eye is not required to have GA

          -  Best Corrected Visual Acuity (BCVA):

               -  SRD part: BCVA of 20/100 to 20/400 Snellen (corresponding to 19 to 53 letters in
                  the ETDRS chart) in the study eye equivalent measured by the Early Treatment
                  Diabetic Retinopathy Study (ETDRS) protocol

               -  MD part: BCVA score of ≤53 letters (Snellen equivalent of 20/100) in the study
                  eye

          -  Age ≥ than 50 years

          -  Best-corrected VA in the non-study eye must have a better best-corrected VA compared
             to the study-eye

          -  Women of childbearing potential (WOCBP) cannot be included. Men able to father a child
             must be ready and able to use highly effective methods of birth control per
             International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate
             of less than 1% per year when used consistently and correctly. A list of contraception
             methods meeting these criteria is provided in the patient information.

          -  Signed informed consent consistent with International Council on Harmonisation Good
             Clinical Practice (ICH GCP) guidelines and local legislation prior to participation in
             the trial, which includes medication washout and restrictions

          -  Not under any administrative or legal supervision or under institutionalization due to
             regulatory or juridical order

        Exclusion criteria

          -  GA in either eye because of causes other than AMD

          -  History of choroidal neovascularization (CNV) in the study eye and in the fellow eye

          -  Previous treatment in the study eye for GA secondary to AMD within 6 months prior to
             screening visit (ongoing therapy with vitamin and mineral supplements is allowed)

          -  Additional eye disease in the study eye that could compromise

               -  best corrected VA (BCVA) with visual field loss,

               -  uncontrolled glaucoma intraocular pressure (IOP>24),

               -  clinically significant diabetic maculopathy,

               -  history of ischemic optic neuropathy or retinal vascular occlusion,

               -  symptomatic vitreomacular traction,

               -  genetic disorders such as retinitis pigmentosa);

               -  history of high myopia > 8 diopters in the study eye and

               -  anterior segment and vitreous abnormalities in the study eye that would preclude
                  adequate observation with Spectral Domain Optical Coherence Tomography (SD-OCT)

          -  Any prior intraocular surgery in the study eye other then uneventful lens replacement
             for cataract within 3 months prior to screening

          -  Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser
             capsulotomy permitted, more than 3 month prior to enrollment in the study eye

          -  Current or planned use of medications known to be toxic to the retina, lens or optic
             nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine,
             phenothiazines, tamoxifen, nicotinic acid, and ethambutol)

          -  Significant disease or other medical conditions (as determined by medical history,
             examination and clinical investigations at screening) that may, in the opinion of the
             investigator result in the any of the following:

               -  Put the patient at risk because of participation in the study

               -  Influence the results of the study,

               -  Cause concern regarding the patient's ability to participate in the study, e.g.
                  cardiac (including tachycardia), gastro-intestinal, hepatic, renal, metabolic,
                  dermatologic, neurological, haematological, oncological and psychiatric.

          -  Patients with malignancy for which the patient has undergone resection, radiation or
             chemotherapy within past 5 years. Patients with treated basal cell carcinoma or fully
             cured squamous cell carcinoma are allowed.

          -  Known hypersensitivity to any of the ingredients used in the Investigational Medical
             Product (IMP) formulation, or any of the medications used

          -  Active intraocular inflammation in the study eye

          -  Active infectious conjunctivitis in either eye

          -  Further exclusion criteria apply