Clinical trial NCT04935411: Russian Registry of Patients With nAMD
Official title: Russian Registry of Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: Neovascular Age-Related Macular Degeneration
nAMD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 2665
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Neovascular Age-Related Macular Degeneration in Russia

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients by gender
timeFrame: Baseline
measure: Age at the diagnosis
timeFrame: Baseline
measure: Percentage of patients with comorbidities and concomitant procedures and medications
timeFrame: Baseline
measure: Patients with unilateral or bilateral disease
timeFrame: Baseline
measure: Time from diagnosis to entry to the registry
timeFrame: Baseline
measure: Social Characteristics (Working and Disability status)
timeFrame: Baseline
measure: Visual acuity
timeFrame: Baseline, up to 2 years
measure: Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment
timeFrame: Baseline, Up to 2 years
measure: Presence of macular atrophy
timeFrame: Baseline, Up to 2 years
measure: Central retinal thickness
timeFrame: Baseline, Up to 2 years
measure: Fluid type
timeFrame: Baseline, Up to 2 years
measure: Indication for intravitreal anti-VEGF therapy
timeFrame: Baseline, Up to 2 years
Secondary outcomes:
measure: Type of prescribed therapy
timeFrame: Up to 2 years
measure: Percentage of patients with prescription of anti-VEGF drugs
timeFrame: Up to 2 years
measure: Time from diagnosis to the therapy initiation
timeFrame: Up to 2 years
measure: Time from diagnosis to anti-VEGF injection
timeFrame: Up to 2 years
measure: Number of visits per year
timeFrame: Up to 2 years
measure: Number of anti-VEGF injections per year
timeFrame: Up to 2 years
measure: Number of Optical coherence tomography (OCTs) done per year
timeFrame: Up to 2 years
measure: Rate of treatment discontinuation
timeFrame: Up to 2 years
measure: Reasons for treatment discontinuation
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: