Russian Registry of Patients With nAMD

Novartis Pharmaceuticals2,665 enrolled

Overview

A three-year, non-randomized, observational, multicenter prospective nAMD study - patient registry.

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

Study Type

OBSERVATIONAL

Enrollment

2,665

Conditions

Neovascular Age-Related Macular Degeneration

Interventions

nAMDOTHER

patients diagnosed with Neovascular Age-Related Macular Degeneration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

Novosibirsk, Russia

Outcomes

Primary Outcomes

Number of patients by gender

Number of patients by gender to be provided

Time frame: Baseline

Age at the diagnosis

Age at the diagnosis to be provided

Time frame: 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

Time frame: Baseline

Patients with unilateral or bilateral disease

Percentage of patients with unilateral or bilateral disease

Time frame: Baseline

Time from diagnosis to entry to the registry

Mean time from diagnosis to entry to the registry to be presented

Time frame: 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)

Time frame: 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

Time frame: Baseline, up to 2 years

Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment

Data from ClinicalTrials.gov

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Secondary Outcomes

Type of prescribed therapy

Type of prescribed therapy (anti-VEGF, PDT, laser coagulation, retinolamine, emoxipine, etc.)

Time frame: 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

Time frame: Up to 2 years

Time from diagnosis to the therapy initiation

Mean time from the diagnosis to the initiation of any therapy for nAMD

Time frame: Up to 2 years

Time from diagnosis to anti-VEGF injection

Mean time from the diagnosis to the first anti-VEGF injection

Time frame: Up to 2 years

Number of visits per year

Number of visits per year to be collected

Time frame: Up to 2 years

Number of anti-VEGF injections per year

Number of anti-VEGF injections to be collected

Time frame: Up to 2 years

Number of Optical coherence tomography (OCTs) done per year

Number of OCTs done per year to be collected

Time frame: Up to 2 years

Rate of treatment discontinuation

Time frame: Up to 2 years

Reasons for treatment discontinuation

Time frame: Up to 2 years