Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 pressure
Substudy:
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
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
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
Any ocular condition that may render the participant at high risk for surgical or treatment complications
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
Suspected or active ocular or periocular infection (e.g., infectious conjunctivitis or endophthalmitis)
