Russian Registry of Patients With nAMD

Study Overview
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Brief Summary
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A three-year, non-randomized, observational, multicenter prospective nAMD study - patient registry.

Detailed Description
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The registry is a structured system which uses observational study methods for systematic collection of data on health condition in the specific patient population. Real world clinical practice data will be collected. Patients will not undergo any additional examinations or procedures that are outside of the standard clinical practice

Official Title
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Russian Registry of Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Conditions
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Neovascular Age-Related Macular Degeneration

Intervention / Treatment
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* Other: nAMD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > to 18 years Male or female patients diagnosed with nAMD (with or without previous treatment for nAMD including but not limited to PDT, laser coagulation, vitamins, retinolamine, emoxipine, anti-VEGF therapy or any surgery for nAMD). Willing and able to provide informed written consent personally or by legal proxy Exclusion Criteria: The patient does not meet the inclusion criteria; The patient is simultaneously participating in a different nAMD therapy study.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| nAMD patients<br>patients diagnosed with Neovascular Age-Related Macular Degeneration | Other: nAMD<br>* patients diagnosed with Neovascular Age-Related Macular Degeneration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients by gender | Number of patients by gender to be provided | Baseline | 
| Age at the diagnosis | Age at the diagnosis to be provided | Baseline | 
| Percentage of patients with comorbidities and concomitant procedures and medications | Percentage of patients with systemic and ophthalmic comorbidities and percentage of patients with concomitant procedures and medications to be provided | Baseline | 
| Patients with unilateral or bilateral disease | Percentage of patients with unilateral or bilateral disease | Baseline | 
| Time from diagnosis to entry to the registry | Mean time from diagnosis to entry to the registry to be presented | Baseline | 
| Social Characteristics (Working and Disability status) | Working status (number of patients that work/does not work, with age-related pension, disability pension). Disability status (number of patients established/not established, removed, disability group, whether AMD is the main reason for disability) | Baseline | 
| Visual acuity | Changes in visual acuity assessed by Sivcev-Golovin's table (The table consists of two parts with 12 rows each, representing visual acuity values between 0.1 and 2.0.) or Snellen equivalent | Baseline, up to 2 years | 
| Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment | Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment. (yes/no) | Baseline, Up to 2 years | 
| Presence of macular atrophy | Presence of macular atrophy (with or without foveal involvement) (yes/no) | Baseline, Up to 2 years | 
| Central retinal thickness | Central retinal thickness to be measured with OCT (optical coherent tomography) | Baseline, Up to 2 years | 
| Fluid type | Type of the fluid assessed by optical coherence tomography and defined as follows: intraretinal fluid (IRF), subretinal fluid (SRF), fluid under repinal pigment epithelium (sub-RPE) | Baseline, Up to 2 years | 
| Indication for intravitreal anti-VEGF therapy | Indication for intravitreal anti-VEGF therapy to be collected | Baseline, Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of prescribed therapy | Type of prescribed therapy (anti-VEGF, PDT, laser coagulation, retinolamine, emoxipine, etc.) | Up to 2 years | 
| Percentage of patients with prescription of anti-VEGF drugs | Percentage of patients with prescription of anti-VEGF drugs to be collected | Up to 2 years | 
| Time from diagnosis to the therapy initiation | Mean time from the diagnosis to the initiation of any therapy for nAMD | Up to 2 years | 
| Time from diagnosis to anti-VEGF injection | Mean time from the diagnosis to the first anti-VEGF injection | Up to 2 years | 
| Number of visits per year | Number of visits per year to be collected | Up to 2 years | 
| Number of anti-VEGF injections per year | Number of anti-VEGF injections to be collected | Up to 2 years | 
| Number of Optical coherence tomography (OCTs) done per year | Number of OCTs done per year to be collected | Up to 2 years | 
| Rate of treatment discontinuation | Rate of treatment discontinuation | Up to 2 years | 
| Reasons for treatment discontinuation | Reasons for treatment discontinuation | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascular Age-Related Macular Degeneration, nAMD