Russian Registry of Patients With nAMD

Neovascular Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04935411
• Other study ID #: CRTH258ARU01
• Status: Terminated
• Start date: December 20, 2020
• Est. completion date: December 5, 2022

Study information

• Verified date: January 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2665
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Other:
• nAMD
patients diagnosed with Neovascular Age-Related Macular Degeneration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients by gender	Number of patients by gender to be provided	Baseline
Primary	Age at the diagnosis	Age at the diagnosis to be provided	Baseline
Primary	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
Primary	Patients with unilateral or bilateral disease	Percentage of patients with unilateral or bilateral disease	Baseline
Primary	Time from diagnosis to entry to the registry	Mean time from diagnosis to entry to the registry to be presented	Baseline
Primary	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
Primary	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
Primary	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
Primary	Presence of macular atrophy	Presence of macular atrophy (with or without foveal involvement) (yes/no)	Baseline, Up to 2 years
Primary	Central retinal thickness	Central retinal thickness to be measured with OCT (optical coherent tomography)	Baseline, Up to 2 years
Primary	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
Primary	Indication for intravitreal anti-VEGF therapy	Indication for intravitreal anti-VEGF therapy to be collected	Baseline, Up to 2 years
Secondary	Type of prescribed therapy	Type of prescribed therapy (anti-VEGF, PDT, laser coagulation, retinolamine, emoxipine, etc.)	Up to 2 years
Secondary	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
Secondary	Time from diagnosis to the therapy initiation	Mean time from the diagnosis to the initiation of any therapy for nAMD	Up to 2 years
Secondary	Time from diagnosis to anti-VEGF injection	Mean time from the diagnosis to the first anti-VEGF injection	Up to 2 years
Secondary	Number of visits per year	Number of visits per year to be collected	Up to 2 years
Secondary	Number of anti-VEGF injections per year	Number of anti-VEGF injections to be collected	Up to 2 years
Secondary	Number of Optical coherence tomography (OCTs) done per year	Number of OCTs done per year to be collected	Up to 2 years
Secondary	Rate of treatment discontinuation	Rate of treatment discontinuation	Up to 2 years
Secondary	Reasons for treatment discontinuation	Reasons for treatment discontinuation	Up to 2 years