Neovascular Age-Related Macular DegenerationNCT04935411
Russian Registry of Patients With nAMD
An observational study of Neovascular Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in Russia.
Trial summary
A three-year, non-randomized, observational, multicenter prospective nAMD study - patient registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- nAMD
- How many people
- 2,665 participants
- Where
- 1 siteRussia
- Study dates
- 20 Dec 2020to 5 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Neovascular Age-Related Macular Degeneration in Russia
Who may be able to join
- 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
Who cannot join
- The patient does not meet the inclusion criteria;
- The patient is simultaneously participating in a different nAMD therapy study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Russian Registry of Patients With Neovascular Age-Related Macular Degeneration (nAMD)
A three-year, non-randomized, observational, multicenter prospective nAMD study - patient registry.
Read the 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
- Being tested
- nAMD
- Keywords
- Neovascular Age-Related Macular Degeneration, nAMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nAMDOther
patients diagnosed with Neovascular Age-Related Macular Degeneration
| Study group | Role | What they receive |
|---|---|---|
| nAMD patients | patients diagnosed with Neovascular Age-Related Macular Degeneration Receives: Other: nAMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients by gender
Number of patients by gender to be provided
Measured: Baseline
Age at the diagnosis
Age at the diagnosis to be provided
Measured: 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
Measured: Baseline
Patients with unilateral or bilateral disease
Percentage of patients with unilateral or bilateral disease
Measured: Baseline
Time from diagnosis to entry to the registry
Mean time from diagnosis to entry to the registry to be presented
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline, Up to 2 years
Presence of macular atrophy
Presence of macular atrophy (with or without foveal involvement) (yes/no)
Measured: Baseline, Up to 2 years
Central retinal thickness
Central retinal thickness to be measured with OCT (optical coherent tomography)
Measured: 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)
Measured: Baseline, Up to 2 years
Indication for intravitreal anti-VEGF therapy
Indication for intravitreal anti-VEGF therapy to be collected
Measured: Baseline, Up to 2 years
Secondary outcomes (9)
Type of prescribed therapy
Type of prescribed therapy (anti-VEGF, PDT, laser coagulation, retinolamine, emoxipine, etc.)
Measured: 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
Measured: Up to 2 years
Time from diagnosis to the therapy initiation
Mean time from the diagnosis to the initiation of any therapy for nAMD
Measured: Up to 2 years
Time from diagnosis to anti-VEGF injection
Mean time from the diagnosis to the first anti-VEGF injection
Measured: Up to 2 years
Number of visits per year
Number of visits per year to be collected
Measured: Up to 2 years
Number of anti-VEGF injections per year
Number of anti-VEGF injections to be collected
Measured: Up to 2 years
Number of Optical coherence tomography (OCTs) done per year
Number of OCTs done per year to be collected
Measured: Up to 2 years
Rate of treatment discontinuation
Rate of treatment discontinuation
Measured: Up to 2 years
Reasons for treatment discontinuation
Reasons for treatment discontinuation
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start20 Dec 2020
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Why it stopped: Enough participants were included, which made it possible to answer the objectives of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935411
- Sponsor's protocol ID
- CRTH258ARU01
- Status last verified
- Aug 2025
- First submitted
- 21 Jun 2021
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Russian Registry of Patients With Neovascular Age-Related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT04935411
- Acronym / sponsor ID
- CRTH258ARU01
- Keywords
- Neovascular Age-Related Macular Degeneration, nAMD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enough participants were included, which made it possible to answer the objectives of the study.
- Enrolment
- 2,665 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nAMD patients | – | Other: nAMDpatients diagnosed with Neovascular Age-Related Macular Degeneration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Neovascular Age-Related Macular Degeneration in Russia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- The patient does not meet the inclusion criteria;
- The patient is simultaneously participating in a different nAMD therapy study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nAMDpatients diagnosed with Neovascular Age-Related Macular Degeneration | Other | nAMD patients |
Primary outcome
Number of patients by gender
Time frame: Baseline
Number of patients by gender to be provided
Age at the diagnosis
Time frame: Baseline
Age at the diagnosis to be provided
Percentage of patients with comorbidities and concomitant procedures and medications
Time frame: 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
Time frame: Baseline
Percentage of patients with unilateral or bilateral disease
Time from diagnosis to entry to the registry
Time frame: Baseline
Mean time from diagnosis to entry to the registry to be presented
Social Characteristics (Working and Disability status)
Time frame: 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
Time frame: 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
Time frame: Baseline, Up to 2 years
Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment. (yes/no)
Presence of macular atrophy
Time frame: Baseline, Up to 2 years
Presence of macular atrophy (with or without foveal involvement) (yes/no)
Central retinal thickness
Time frame: Baseline, Up to 2 years
Central retinal thickness to be measured with OCT (optical coherent tomography)
Fluid type
Time frame: 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
Time frame: Baseline, Up to 2 years
Indication for intravitreal anti-VEGF therapy to be collected
9 secondary outcomes
Type of prescribed therapy
Time frame: Up to 2 years
Percentage of patients with prescription of anti-VEGF drugs
Time frame: Up to 2 years
Time from diagnosis to the therapy initiation
Time frame: Up to 2 years
Time from diagnosis to anti-VEGF injection
Time frame: Up to 2 years
Number of visits per year
Time frame: Up to 2 years
Number of anti-VEGF injections per year
Time frame: Up to 2 years
Number of Optical coherence tomography (OCTs) done per year
Time frame: Up to 2 years
Rate of treatment discontinuation
Time frame: Up to 2 years
Reasons for treatment discontinuation
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Enough participants were included, which made it possible to answer the objectives of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enough participants were included, which made it possible to answer the objectives of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients by gender (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.