A Dose Escalation Trial of an Intravitreal Injection of Sirna-027 in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study will be to assess the safety and tolerability and dose-limiting toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the anatomical changes in the retina, changes in CNV, and changes in visual acuity. Escalation to the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will be monitored intensively for three months, and then followed-up for safety up to 24 months post-injection.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Active AMD with Subfoveal CNV (classic and/or occult CNV)
- CNV lesion thickness >/= 250um by OCT assessment
- Visual acuity in study eye of </= 20/100 but not worse than 20/800
- Not eligible for or refused standard treatment
Exclusion criteria
- Females of childbearing potential
- Other causes of CNV including pathologic myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
- Any intraocular surgery or treatment of AMD with Visudyne within 3 months of study entry
- CNV lesion >/= 12 MPS disc area
Trial design
Primary purpose
Allocation
Interventional model
Masking
26 participants in 6 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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