This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks
The development of biologic therapy targeting VEGF has been revolutionary and has lowered the rate of functional blindness in many developed countries. Modalities to treat nvAMD have been based on monthly dosing. For many patients, this modality is adequate and they can achieve a dry macula. A subset of patients can even have their treatment intervals extended. There is, however, a subset of patients with recalcitrant neovascularization for whom IAI fails to produce a dry macula even with q4w dosing. An intense dosing schedule for a short period of time could decrease fluid activity in these patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy
Vitreous Retina Macula Consultants of New York
New York, New York, United States
RECRUITINGIncidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy
Time frame: Baseline to 12 weeks
Mean change in BCVA from baseline to week 12
Time frame: Baseline to week 12
Mean change in BCVA from baseline to week 52
Time frame: Baseline to week 52
Number of patients who are able to maintain a dry macula with IAI intervals extending beyond q4w.
Time frame: Baseline to week 52
Mean number of injections to achieve fluid-free status and at week 12 and week 52
Time frame: Baseline to week 52
Incidence and severity of adverse events through week 52
Time frame: Baseline to week 52
Polyp size reduction or closure - compare polyp and lesion area size to baseline on Heidelberg Eye Explorer software (Tan 2015), OCTA and ICG angiography (ICGA)
Time frame: Baseline to week 52
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Time frame: Baseline to week 12
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Time frame: Baseline to week 52
Mean change in lesion
Time frame: Baseline to week 12
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Mean change in lesion
Time frame: Baseline to week 52
Number of patients whose fovea remain dry upon extending to q4w IAI at week 52
Time frame: Baseline to week 52
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid
Time frame: Baseline to week 12
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid
Time frame: Baseline to week 52