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

Korábbi kezelés

• Cerebrovascular accident or myocardial infarction within 6 months prior to randomization
• Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
• Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in Study GR40550) within 6 months prior to enrollment
• Use of antimitotic or antimetabolite therapy within 30 days
  • Ocular Exclusion Criteria for Study Eye:
• Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
• Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
• History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
• Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
• Concurrent conjunctival, tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant

Más betegség

• 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
• Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
• Current systemic treatment for a confirmed active systemic infection
• Any ocular condition that may render the participant at high risk for surgical or treatment complications
• Suspected or active ocular or periocular infection (e.g., infectious conjunctivitis or endophthalmitis)
• Any history of uveitis

Laborértékek

• Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications

Egyéb

• High-risk PDR
• Active intraocular inflammation (grade trace or above)
• Uncontrolled blood pressure
  • Substudy:
• Ongoing ocular complications that might affect participant safety Ocular Exclusion Criteria for Either Eye
• Active blepharitis

• 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)
• Having experienced a septum dislodgement in the original implant while in the main study or after exiting the main study
• Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center