A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
Trial Parameters
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Brief Summary
This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years at time of signing informed consent form (ICF) * Documented diagnosis of diabetes mellitus (Type 1 or Type 2) * Glycated haemoglobin (HbA1c) level of ≤10% within 2 months prior to screening or at screening Study eye * Macular thickening secondary to DME involving the center of the fovea with CST ≥325 micrometer (µm) on SD-OCT at screening * BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent) Exclusion Criteria: * High-risk PDR * Active intraocular inflammation (grade trace or above) * Suspected or active ocular or periocular infection of either eye * Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study * Cerebrovascular accident or myocardial infarction within 6 months prior to randomization * Atrial fibrillation diagnosis or worsening within 6 months prior to randomization * Uncontrolled blood