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
Macular Degeneration
About this trial
This is an interventional treatment trial for Macular Degeneration
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
Sites / Locations
- Retina-Vitreous Associates Medical Group
- Retina Specialty Institute
- Center for Retina and Macular Disease
- Southeast Retina Center, PC
- Western Carolina Retinal Associate PA
- Mid Atlantic Retina
- Retina Consultants of Texas
- Retina Foundation of the Southwest
- Bristol Eye Hospital
- Royal Liverpool University Hospital
- Moorfields Eye Hospital
- Royal Victoria Infirmary
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
0.3 mg BI 754132 - SRD part
1 mg BI 754132 - SRD part
3 mg BI 754132 - SRD part
6 mg BI 754132 - SRD part
6 mg BI 754132 - MD part
0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.
1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose.