Recurrent Neovascular Age-related Macular Degeneration After Therapy Suspension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate prospectively the recurrence rate of active macular neovascularization (MNV) and the visual outcome in patients with nAMD previously on a Treat and Extend regimen where treatment has been discontinued due to disease stability.

Detailed Description
-----------------
All study subjects had nAMD and were treated at diagnosis with three monthly aflibercept injections and then subsequently followed in a treat and extend regimen with extensions by two weeks if no signs of disease activity were seen. Hemorrhage, intraretinal macular edema or subretinal fluid were considered signs of disease activity. Patients reaching 12-week intervals without any evidence of disease activity on three consecutive visits, a BCVA between 35-88 letters (Snellen 20/200- 20/20) and a near vision of at least 24 points were eligible for study inclusion. If there were signs of recurrent disease activity during the follow-up, study participation was concluded at that point and intravitreal therapy was resumed. Between scheduled visits patients were encouraged to monitor their vision at home using monocular visual assessments and were advised to return earlier than planned if symptoms of visual deterioration or metamorphopsia occurred. At baseline and at every follow-up visit all patients had a full dilated ophthalmic examination. Optical coherence tomography (OCT) images were obtained by using the Zeiss Cirrus OCT instrument (Carl Zeiss Meditec, Inc.,Dublin, Ca). A pigment epithelial detachment (PED) was identified as an elevation of the RPE band and included both serous and fibrovascular PED. Near vision was tested at 40cm with the addition of +3 dioptres to the BCVA refraction. For near vision assessment we used the LIX adult A chart (Ortho-KM, Lund, Sweden) graded in typographical points, the largest text being 24 points and the smallest 4 points.

Official Title
-----------------
Recurrent Neovascular Age-related Macular Degeneration After Discontinuation of VEGF Inhibitors Managed in a Treat and Extend Regimen

Conditions
-----------------
Age-related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with inactive neovascular AMD reaching 12-week intervals in a treat and extend regimen without any evidence of disease activity on three consecutive visits. BCVA between 35-88 letters (Snellen 20/200- 20/20) Near vision of at least 24 points Exclusion Criteria: • Active neovascular AMD

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease recurrence | The proportion of patients with recurrent disease within 12 months after the last injection. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for disease recurrence | Effect of age, lesion type, anatomic parameters (PED, geographic atrophy (GA) and sub macular fibrosis), previous episodes of recurrence and total number of injections before suspension, on risk of reactivation. | 12 months | 
| Visual outcome | Change in BCVA at time of recurrence and after resumed therapy. | 12 months |