A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration

A regiszterben nem jelölt feltételek

• General Key Inclusion Criteria
• Written informed consent before the first study-related activity
• Be male or female ≥ 18 years of age
• If female, have a negative serum pregnancy test at Screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential.
  • General Key Exclusion Criteria
• Be pregnant or breastfeeding
• Have a history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
• Have uncontrolled blood pressure, defined as systolic ≥180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest.
• Have had Yttrium-Aluminum Garnet laser capsulotomy in the study eye within 90 days of Screening
• Have had Pan-retinal Photocoagulation or focal thermal laser photocoagulation in the study eye
• Have tractional retinal detachment in the study eye
• Have uncontrolled glaucoma (defined as IOP ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye
  • BRVO-specific Inclusion Criteria
  • Participants must:
• Be diagnosed with BRVO in the study eye
• Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
• Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
• Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO BRVO-specific Exclusion Criteria
  • Participants must not:
• Have macular edema in the study eye considered to be secondary to a cause other than BRVO (e.g., DME, Irvine-Gass syndrome)
• Have active iris or angle neovascularization or neovascular glaucoma in the study eye
• Have proliferative retinopathy, central retinal vein occlusion, or hemiretinal vein occlusion
  • DME-specific Inclusion Criteria
  • Participants must:
• Have Type 1 or Type 2 diabetes mellitus and a glycated hemoglobin A1c (HbA1c) of ≤ 12%
• Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
• Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
• Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of DME
  • DME-specific Exclusion Criteria
  • Participants must not:
• Have macular edema in the study eye considered to be secondary to a cause other than DME (eg, retinal vein occlusion, Irvine-Gass syndrome)
• Have active iris or angle neovascularization or neovascular glaucoma in the study eye
• Have high-risk proliferative diabetic retinopathy characteristics in the study eye
  • NVAMD-specific Inclusion Criteria
  • Participants must:
• Be ≥ 50 years of age
• Have a ETDRS BVCA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
• Subfoveal CNV secondary to AMD, with a total lesion size (including blood, scar/atrophy \& neovascularization) of ≤ 9-disc areas, of which at least 50% must be active CNV in the study eye
• Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
• Be treatment naïve with vision loss in the study eye secondary to NVAMD diagnosed within 21 days prior to the Day 1 study treatment NVAMD-specific Exclusion Criteria
  • Participants must not:
• Have had previous thermal subfoveal laser therapy in the study eye
• Have any subfoveal atrophy or scarring, blood over the fovea, or subfoveal fibrosis in the study eye. Additionally, no more than 25% of the total lesion size may be made up of scarring or atrophy
• Have had previous photodynamic therapy with Visudyne in the study eye
• Have diabetic retinopathy in the study eye