The purpose of this Phase 4 study is to evaluate the safety of aflibercept 8mg in patients with proliferative diabetic retinopathy without center-involved diabetic macular edema.
Subjects will be administered intravitreal aflibercept 8mg every 4 weeks, starting at week 0 for 8 weeks, then may be extended by 4-week intervals with no maximum between treatments with an end of study visit at week 96. At any visit, it will be determined if supplemental treatment is needed as determined by disease activity assessment until there is no regression of disease is noted and the extension intervals will begin again.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Solution in Vial, intravitreal (IVT) injection
Primary Endpoint - DRSS step improvement
Proportion of eyes with ≥ 2 step improvement in diabetic retinopathy severity scale (DRSS), as assessed by the central reading center
Time frame: Baseline through weeks 48 and 96
DRSS Step Improvement
Proportion of eyes with ≥ 2 step improvement in diabetic retinopathy severity scale (DRSS), as assessed by the central reading center
Time frame: Baseline to week 24 and 96
Mean change in BCVA
Evaluate the mean change in the best corrected visual acuity (BCVA)
Time frame: Baseline through weeks 24, 48, 72, and 96
Conversion from PDR to NPDR
Proportion of eyes converting from proliferative diabetic retinopathy (PDR) to non-proliferative diabetic retinopathy (NPDR)
Time frame: Baseline to weeks 24, 48, 72, 96.
DRSS Step Improvement
Proportion of eyes with \>= 3 step improvement in diabetic retinopathy severity scale (DRSS)
Time frame: Baseline to weeks 24, 48, 72, 96
Retinal non-perfusion change
Mean change (quantitative area) in retinal vascular non-perfusion (RNP) based on ultrawide-field fluorescein angiography (UWFA)
Time frame: Baseline to weeks 24, 48, 72, 96.
Changes in visual function on HVF
Mean change in Humphrey visual field 30-2 total point score
Time frame: Baseline to weeks 48, 96.
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CST change
Mean change in CST
Time frame: Baseline to weeks 24, 48, 72, 96
Number of supplemental treatments
Mean and median number of intravitreal (IVT) 8mg aflibercept injections (with and without intravitreal 8 mg aflibercept injections given for DME) as well as annualized injection frequencies
Time frame: Baseline through week 96
Worsening PDR
Mean time to development of worsening proliferative diabetic retinopathy associated event/s, including PDR-related vitrectomy, new or worsening preretinal or vitreous hemorrhage, retinal detachment, panretinal photocoagulation
Time frame: Baseline to week 96
CI-DME development
Mean time to development of central-involved DME (CI-DME)
Time frame: Baseline to week 96
AEs notated
Incidence and severity of ocular and systemic adverse events
Time frame: Baseline to week 96