Russian Registry of Patients With nAMD
Study Details
Study Description
Brief Summary
A three-year, non-randomized, observational, multicenter prospective nAMD study - patient registry.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| nAMD patients patients diagnosed with Neovascular Age-Related Macular Degeneration |
Other: nAMD
patients diagnosed with Neovascular Age-Related Macular Degeneration
|
Outcome Measures
Primary Outcome Measures
- Number of patients by gender [Baseline]
Number of patients by gender to be provided
- Age at the diagnosis [Baseline]
Age at the diagnosis 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
- 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
- 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)
- 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)
- Presence of macular atrophy [Baseline, Up to 2 years]
Presence of macular atrophy (with or without foveal involvement) (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
Secondary Outcome Measures
- 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 the therapy initiation [Up to 2 years]
Mean time from the diagnosis to the initiation of any therapy for nAMD
- 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
- Number of Optical coherence tomography (OCTs) done per year [Up to 2 years]
Number of OCTs done per year 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Novosibirsk | Russian Federation | 630087 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRTH258ARU01