Recalcitrant Wet Age-related Macular Degeneration
Conditions
Brief summary
The purpose of the study is to determine the effectiveness of Ranibizumab 0.5 mg or 1.0 mg in subjects who were previously treated with Bevacizumab and subsequently switched to Aflibercept. These subjects have demonstrated a sub-optimal therapeutic response to the previous therapies; therefore, the study aims to see if Ranibizumab may have a greater treatment effect.
Interventions
DRUGRanibizumab
Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.
Sponsors
Genentech, Inc.
Northern California Retina Vitreous Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age greater than or equal to 50 years * Best-corrected ETDRS VA between 20/25 to 20/320 * Total area of subretinal hemorrhage and/or fibrosis comprising less than 50% of lesion * Any neovascular lesion type of ARMD having previously received at least 3 doses 1.25 mg of bevacizumab and/or ranibizumab (minimum 3 monthly injections) followed by 3 monthly doses of aflibercept 2.0 mg (with last injection being within 8 weeks) with evidence of recalcitrant ARMD, defined by at least one of the following: persistent subretinal fluid with or without intraretinal cystic edema on SD-OCT and/or leakage on fluorescein angiography
Exclusion criteria
* Pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Participation in another simultaneous medical investigation or trial * History of prior vitrectomy surgery * Previous treatment with photodynamic therapy, radiation, or any other intravitreal drug delivery, such as dexamethasone or triamcinolone * Subretinal hemorrhage involving the central fovea \> 1 disc area, subfoveal atrophy * CNVM secondary to causes other than ARMD * Previous retinal pigment epithelial tear
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in vision | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in BCVA | 3 months, 9 months, and 12 months |
| Mean change in SD-OCT central foveal thickness | 3 months, 6 months, 9 months, and 12 months |
| Percentage of recalcitrant patients that respond by either OCT or VA to Ranibizumab after not having a complete response to previous therapy | 12 months |
| Percentage of patients that need to be escalated to 1 mg therapy | 12 months |
Countries
United States
Outcome results
None listed