AMD - Age-Related Macular DegenerationNCT07427160
Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages
An observational study of AMD - Age-Related Macular Degeneration, run by Marco Mazzola at 1 site in Italy.
Trial summary
This study investigates the prognostic value of macular neovascularization (MNV) subtypes in patients treated with pneumatic displacement for submacular hemorrhage. The researchers will compare anatomical and functional outcomes (visual acuity) between PCV, RAP, and other MNV forms within a Caucasian cohort to… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AMD - Age-Related Macular Degeneration
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2025to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of Caucasian patients, aged 50 years or older, diagnosed with submacular hemorrhage (SMH) secondary to macular neovascularization (MNV). All participants underwent pneumatic displacement treatment at the Multizonal Ophthalmology Unit of the Provincial Agency for Healthcare Services (APSS) in Trento and Rovereto, Italy, between December 1, 2016, and May 31, 2023.
Who may be able to join
- Patients undergoing pneumatic displacement (PD) for submacular hemorrhage (SMH), secondary to macular neovascularization (MNV)
- Age 50 years or older at the time of SMH diagnosis
- Caucasian ethnicity
- SMH involving the central or internal ring of the Early Treatment Diabetic Retinopathy Study (ETDRS) grid (within a 3 mm circumference centered on the fovea)
- SMH dimensions equal to or greater than one papillary diameter
- Pneumatic displacement treatment performed within 36 hours of SMH diagnosis
Who cannot join
- SMH estimated to be present for more than 15 days at the time of diagnosis
- SMH secondary to conditions other than MNV
- Presence of proliferative diabetic retinopathy in the study eye
- Aphakia in the study eye
- Inadequate pupillary dilation, media opacities, or other impediments to retinal imaging
- Previous pneumatic displacement procedures for SMH in the study eye
- Ocular surgery in the 8 weeks preceding the pneumatic displacement intervention
- Follow-up duration of less than 6 months following the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Santa Chiara Di Trento
Trento, Trento, 38122
marco mazzola, MD, +39479950266, marco.mazzola@asuit.tn.it
tommaso brighenti, MD, tommaso.brighenti@asuit.tn.it
About this study
This study investigates the prognostic value of macular neovascularization (MNV) subtypes in patients treated with pneumatic displacement for submacular hemorrhage. The researchers will compare anatomical and functional outcomes (visual acuity) between PCV, RAP, and other MNV forms within a Caucasian cohort to identify subtype-specific predictors of recovery.
- Conditions
- AMD - Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCV | Patients with submacular hemorrhage secondary to Polypoidal Choroidal Vasculopathy (PCV) | |
| RAP | Patients with submacular hemorrhage secondary to Retinal Angiomatous Proliferation (RAP), also known as Type 3 MNV | |
| Other MNV | Patients with submacular hemorrhage secondary to other forms of Macular Neovascularization (MNV) not classified as PCV or RAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical success rate of pneumatic displacement
Percentage of patients achieving successful subretinal hemorrhage displacement, defined as the absence of subretinal blood within the internal ring of the ETDRS grid (3 mm centered on the fovea) at the first post-operative OCT
Measured: 5-8 days post-treatment
Change in Best-Corrected Visual Acuity (BCVA)
Evaluation of the difference in visual acuity from baseline to the 6-month follow-up. Snellen chart measurements will be converted to LogMAR for statistical analysis.
Measured: Baseline and 6 months.
Secondary outcomes (1)
Change in Central Retinal Thickness
Measurement of retinal thickness (in microns) using Spectralis HRA+OCT to evaluate the anatomical response to treatment.
Measured: Baseline, 1 month, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start15 Oct 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMD - Age-Related Macular DegenerationStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Mazzola
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Mazzola, Azienda Sanitaria Universitaria Integrata del Trentino
- Investigators
- marco mazzola, MD, Principal investigator, Azienda Sanitaria Universitaria Integrata del Trentino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427160
- Sponsor's protocol ID
- GAS.MNV
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages
- ClinicalTrials.gov ID
- NCT07427160
- Acronym / sponsor ID
- GAS.MNV
- Conditions
- AMD - Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marco MazzolaUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 23 Feb 2026 (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.
This study investigates the prognostic value of macular neovascularization (MNV) subtypes in patients treated with pneumatic displacement for submacular hemorrhage. The researchers will compare anatomical and functional outcomes (visual acuity) between PCV, RAP, and other MNV forms within a Caucasian cohort to identify subtype-specific predictors of recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCV | – | –Patients with submacular hemorrhage secondary to Polypoidal Choroidal Vasculopathy (PCV) |
| RAP | – | –Patients with submacular hemorrhage secondary to Retinal Angiomatous Proliferation (RAP), also known as Type 3 MNV |
| Other MNV | – | –Patients with submacular hemorrhage secondary to other forms of Macular Neovascularization (MNV) not classified as PCV or RAP |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of Caucasian patients, aged 50 years or older, diagnosed with submacular hemorrhage (SMH) secondary to macular neovascularization (MNV). All participants underwent pneumatic displacement treatment at the Multizonal Ophthalmology Unit of the Provincial Agency for Healthcare Services (APSS) in Trento and Rovereto, Italy, between December 1, 2016, and May 31, 2023.
Key inclusion criteria (6 listed)
- Patients undergoing pneumatic displacement (PD) for submacular hemorrhage (SMH), secondary to macular neovascularization (MNV)
- Age 50 years or older at the time of SMH diagnosis
- Caucasian ethnicity
- SMH involving the central or internal ring of the Early Treatment Diabetic Retinopathy Study (ETDRS) grid (within a 3 mm circumference centered on the fovea)
- SMH dimensions equal to or greater than one papillary diameter
Key exclusion criteria (8 listed)
- SMH estimated to be present for more than 15 days at the time of diagnosis
- SMH secondary to conditions other than MNV
- Presence of proliferative diabetic retinopathy in the study eye
- Aphakia in the study eye
- Inadequate pupillary dilation, media opacities, or other impediments to retinal imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anatomical success rate of pneumatic displacement
Time frame: 5-8 days post-treatment
Percentage of patients achieving successful subretinal hemorrhage displacement, defined as the absence of subretinal blood within the internal ring of the ETDRS grid (3 mm centered on the fovea) at the first post-operative OCT
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline and 6 months.
Evaluation of the difference in visual acuity from baseline to the 6-month follow-up. Snellen chart measurements will be converted to LogMAR for statistical analysis.
1 secondary outcome
Change in Central Retinal Thickness
Time frame: Baseline, 1 month, 3 months, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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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.
marco mazzola, MD principal investigator
Azienda Sanitaria Universitaria Integrata del Trentino
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 AMD - Age-Related Macular Degeneration, run by Marco Mazzola at 1 site in Italy.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact marco mazzola, medical doctor (+393479950266, marco.mazzola@asuit.tn.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical success rate of pneumatic displacement (time frame: 5-8 days post-treatment). The study lists 2 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 23 Feb 2026.