Study for Recalcitrant Age Related Macular Degeneration (TURF)
50 Patients with recalcitrant exudative age-related macular degeneration with a history of retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of ranibizumab.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||AflibercepT for Subjects Who Are Incomplete Responders to mUltiple Intravitreal Injections of Ranibizumab, Anti-VegF (The TURF Study)|
- The percentage of patients with no fluid on OCT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mean change in OCT central foveal thickness [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Time to resolution of intraretinal cysts and sub retinal fluid on OCT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The percentage of patients who lose < 15 letters visual acuity [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Mean change in visual acuity (BCVA) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Quantitative change in area (μ) from baseline in choroidal neovascular lesion characteristics/size as measured by FA/Fundus photos [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Data measurement [ Time Frame: at least 12 months from 6 months completion visit ] [ Designated as safety issue: No ]an evaluation visit for all enrolled patients to occur no earlier than 12 months after completion of the last scheduled visit during Interventional period (6 months from Visit 1)
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Drug: aflibercept 2.0 mg
The rationale for the TURF trial is based on the greater binding affinity of VEGF Trap-eye, which theoretically may prove to be more effective for recalcitrant wet AMD and therefore may demonstrate a positive impact on visual acuity and the foveal anatomy of subjects who have a history of a less than optimal anatomical and visual response to multiple intravitreal injections of 2.0mg (super-dose) ranibizumab. Based on the anatomical data from the VIEW1 and VIEW2 trials, approximately 70% of VEGF-Trap eye patients had no evidence of fluid on OCT compared to approximately 55% of ranibizumab patients. One potential interpretation of this clinical data is that the increased binding affinity and longer half-life of VEGF-Trap eye result in the resolution of more fluid for a longer duration of effect.
Patients to be enrolled in this study have a history of requiring monthly dosing of ranibizumab 2.0mg to achieve maximum resolution of fluid on OCT and increased visual acuity. These patients initially showed minimal fluid resolution visual acuity gains while treated with Lucentis (0.5mg ranibizumab) and were subsequently treated with 2.0mg monthly. It is expected that treating these same patients with 2.0mg EYLEA™ (aflibercept injection for eye) will maintain the fluid resolution on OCT and visual acuity gains previously requiring a super-dose of ranibizumab.
|United States, Texas|
|Retina Consultants of Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David M Brown, MD||Director Greater Houston Research|