Evaluation of EYS606 in Patients With Non-infectious Posterior, Intermediate or Panuveitis (NCT03308045) | Clinical Trial Compass
CompletedPhase 1/2
Evaluation of EYS606 in Patients With Non-infectious Posterior, Intermediate or Panuveitis
France, United Kingdom15 participantsStarted 2017-04-04
Plain-language summary
Primary objective: safety and tolerability
Secondary objectives: additional indicators of long term safety and indicators of clinical activity
Exploratory objectives: to characterize EYS606 biodistribution, immunogenicity and biomarkers
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must be 18 years of age or older
* Both female patients of childbearing potential and male patients able to father a child must agree to practice at least one effective method of birth control for six months following administration of study medication. Acceptable methods of birth control for this study include hormonal contraception (birth control pills, injected hormones, dermal patch or vaginal ring), intrauterine device, barrier methods (diaphragm, condom) with spermicide or surgical sterilization (hysterectomy, tubal ligation or vasectomy). Patients with a hysterectomy or vasectomy (or have a partner with a hysterectomy or vasectomy) are exempt from using these methods of birth control.
* Female patients of childbearing potential must not be pregnant or breast-feeding and must have a negative urine pregnancy test at baseline and throughout the study.
* Voluntary written informed consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
* Patient has only one eligible eye with the following criteria:
* non-infectious intermediate, posterior, or panuveitis,
* media clarity, pupillary dilation, and individual cooperation sufficient for adequate fundus imaging,
* macular atrophy, AND/OR degenerative macular edema, AND/OR advanced optic neuropathy, AND/OR macular scar,
* Patients must maintain…
What they're measuring
1
Number of patients with treatment emergent adverse events