A Phase 1/2 interventional study of Aflibercept Injection in Neovascular Age-Related Macular Degeneration, sponsored by Vitreous -Retina- Macula Consultants of New York. Status unknown at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by Vitreous -Retina- Macula Consultants of New York · Phase 1/2, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 30 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Vitreous -Retina- Macula Consultants of New York is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.
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.
Drug: Aflibercept Injection
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.
Drug: Aflibercept Injection
Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy
Also known as: Eylea
Incidence 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
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
Plan to share: Undecided
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This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Vitreous -Retina- Macula Consultants of New York