Russian Registry of Patients With nAMD

Terminated

• Conditions: Neovascular Age-Related Macular Degeneration
• Interventions: Other: nAMD

• Registration Number: NCT04935411
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2020-12-20
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-23
• Primary Completion: 2022-12-05
• Study Completion: 2022-12-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2665

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

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Exclusion Criteria

• The patient does not meet the inclusion criteria;
• The patient is simultaneously participating in a different nAMD therapy study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nAMD patients	nAMD	patients diagnosed with Neovascular Age-Related Macular Degeneration

Primary Outcome Measures

Name	Time	Method
Number of patients by gender	Baseline	Number of patients by gender to be provided
Percentage of patients with comorbidities and concomitant procedures and medications	Baseline	Percentage of patients with systemic and ophthalmic comorbidities and percentage of patients with concomitant procedures and medications to be provided
Presence of macular atrophy	Baseline, Up to 2 years	Presence of macular atrophy (with or without foveal involvement) (yes/no)
Age at the diagnosis	Baseline	Age at the diagnosis to be provided
Patients with unilateral or bilateral disease	Baseline	Percentage of patients with unilateral or bilateral disease
Time from diagnosis to entry to the registry	Baseline	Mean time from diagnosis to entry to the registry to be presented
Visual acuity	Baseline, up to 2 years	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
Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment	Baseline, Up to 2 years	Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment. (yes/no)
Central retinal thickness	Baseline, Up to 2 years	Central retinal thickness to be measured with OCT (optical coherent tomography)
Fluid type	Baseline, Up to 2 years	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)
Indication for intravitreal anti-VEGF therapy	Baseline, Up to 2 years	Indication for intravitreal anti-VEGF therapy to be collected
Social Characteristics (Working and Disability status)	Baseline	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)

Secondary Outcome Measures

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