|Principal Investigator: Rachael Jacoby|
|Keywords: diabetic eye disese||Department: Ophthalmology-Services|
|IRB Number: 00136057|
|Specialty: Ophthalmology, Ophthalmology|
|Sub Specialties: Diabetic Retinopathy, Retinal Diseases|
|Recruitment Status: Enrolling by invitation|
To evaluate the long-term use of faricimab in treating diabetic macular edema
Patients must meet the following criteria for study entry:
Previous enrollment in and completion of Study GR40349 (YOSEMITE IRB # 115547) or GR40398 (RHINE - our site did not participate in the RHINE study), without study or study drug discontinuation.
Signed Informed Consent Form
Ability to comply with the study protocol, in the investigator's judgment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the final dose of study treatment
A woman is considered to be of childbearing potential if she is postmenarcheal, has
not reached a postmenopausal state (>12 continuous months of amenorrhea with no
identified cause other than menopause), and has not undergone surgical sterilization
(removal of ovaries and/or uterus). The definition of childbearing potential may be
adapted for alignment with local guidelines or requirements.
Examples of acceptable contraceptive methods include bilateral tubal ligation, male
sterilization; hormonal contraceptives that inhibit ovulation, hormone-releasing
intrauterine devices and copper intrauterine devices.
Contraception methods that do not result in a failure rate of < 1% per year such as
male or female condom with or without spermicide; and cap, diaphragm, or sponge
with spermicide are not acceptable.
The reliability of sexual abstinence should be evaluated in relation to the duration of
the clinical trial and the preferred and usual lifestyle of the patient. If a patient is
usually not sexually active but becomes active, they, with their partner, must comply
with the contraceptive requirements of the study.
Patients who meet any of the following criteria will be excluded from study entry:
Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final ITV injection of faricimab
Women of childbearing potential must have a negative urine pregnancy test result
within 28 days prior to initiation of study treatment. If the urine pregnancy test is
positive, it must be confirmed by a serum pregnancy test.
Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
Requirement for continuous use of any medications or treatments indicated as prohibited therapy
The overall stipend amount will vary from patient to patient, depending on their treatment interval. Some patients will have study visits every 4 weeks, others will have study visits every 16 weeks. All patients will have a minimum of 7 visits, for a total of $700