Aflibercept in Recurrent or Persistent CNV

Study Overview
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Brief Summary
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Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process. The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to the current routine therapy using aflibercept in eyes with treatment naive, recurrent or persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy. 20 patients with recurrent or persistent nAMD, previously treated with intravitreal ranibizumab for up to one year will be included in this trial. Patients will be examined in monthly intervals over 12 months follow-up. Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl. funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence fundus image (AF) & red-free autofluorescence fundus image (RF), Color fundus photography (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry (MP), as well as Non-invasive OCT based optical angiography (AngioVue).

Official Title
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Response to Aflibercept After Previous Intravitreal Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration

Conditions
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Age Related Macular Degeneration, Intravitreal Injections, Diabetic Macular Edema

Intervention / Treatment
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* Drug: Aflibercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 50 years Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year BCVA >= 20/400 in the study eye using ETDRS Willingness and ability to comply with regular visits Signed informed consent Exclusion Criteria: Any surgical treatment of the eye within 3 months prior to baseline in the study eye History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation) Aphakia or absence of the posterior capsule (excluding YAG-capsulotomy) in the study eye Retinal pigment epithelial tear involving the macula in the study eye

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AMD patients previously teated with Lucentis<br>Adults ≥ 50 years; Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; Willingness and ability to comply with regular visits; Signed informed consent form; The patient can take his medicine in the prescribed manner. The prescribed drugs do not constitute an exclusion criteria. | Drug: Aflibercept<br> <br> |
| treatment naive AMD patients<br>Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; | Drug: Aflibercept<br> <br> |
| DME patients previously teated with Lucentis<br>Adults ≥ 50 years; Patients who have been treated with ranibizumab due to DME for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; | Drug: Aflibercept<br> <br> |
| treatment naive DME patients<br>Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; | Drug: Aflibercept<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Best-Corrected Visual Acuity (BCVA) |  | After one year compared to baseline | 
| Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos) |  | after one year compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retreatments |  | after one year |