Intense Treatment Regimen With Intravitreal Aflibercept Injection for Refractory Neovascular Age-Related Macular Degeneration With or Without Polypoidal Choroidal Vasculopathy
Overview
- Phase
- Phase 1
- Intervention
- Aflibercept Injection
- Conditions
- Neovascular Age-Related Macular Degeneration
- Sponsor
- Vitreous -Retina- Macula Consultants of New York
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy
- Last Updated
- 7 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 50 years
- •Choroidal neovascularization related to age-related macular degeneration
- •Prior treatment with any anti-VEGF agent for ≥ 12 months
- •Prior treatment with at least five consecutive IAI at baseline with an average treatment interval of maximum 35 days
- •Presence of foveal fluid at most recent clinical visit occurring 30 (+/- 5) days following the most recent IAI
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
Exclusion Criteria
- •A patient who meets any of the following criteria will be excluded from the study:
- •Monocular patients
- •Patients with a previous history of macular thermal laser or PDT
- •Confounding ocular conditions in the study eye that may affect interpretation of OCT, BCVA or assessment of macular appearance (eg. cataract, epiretinal membrane, retinal vascular occlusive disease)
- •Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- •Active intraocular inflammation (grade trace or above) in the study eye
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- •Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
- •History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment
Arms & Interventions
2mg IAI q2w
2mg Intravitreal Aflibercept injection will be given every 2 weeks starting at baseline and then at weeks 2, 4, 6, 8, 10 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52.
Intervention: Aflibercept Injection
2mg IAI q3w
2mg Intravitreal Aflibercept injection will be given every 3 weeks starting at baseline and then at weeks 3, 6, 9 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52.
Intervention: Aflibercept Injection
Outcomes
Primary Outcomes
Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy
Time Frame: Baseline to 12 weeks
Secondary Outcomes
- Mean change in BCVA from baseline to week 12(Baseline to week 12)
- Mean change in BCVA from baseline to week 52(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)(Baseline to week 52)
- Mean change to area of flow within neovascular network on OCT-angiography (OCTA)(Baseline to week 52)
- Number of patients whose fovea remain dry upon extending to q4w IAI at week 52(Baseline to week 52)
- Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid(Baseline to week 52)
- Number of patients who are able to maintain a dry macula with IAI intervals extending beyond q4w.(Baseline to week 52)
- Mean number of injections to achieve fluid-free status and at week 12 and week 52(Baseline to week 52)
- Incidence and severity of adverse events through week 52(Baseline to week 52)
- Mean change in lesion(Baseline to week 52)