Russian Registry of Patients With nAMD

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

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

Study Overview

• Status: Terminated
• Conditions: Neovascular Age-Related Macular Degeneration
• Intervention / Treatment: Other: nAMD

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

• Study Type: Observational
• Enrollment (Actual): 2665

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Neovascular Age-Related Macular Degeneration in Russia

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
nAMD patients; patients diagnosed with Neovascular Age-Related Macular Degeneration	Other: nAMD; patients diagnosed with Neovascular Age-Related Macular Degeneration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2020
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 5, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Neovascular Age-Related Macular Degeneration; nAMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: CRTH258ARU01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No