How macular neovascular membrane type affects recovery after pneumatic displacement for macular hemorrhage
Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages
This project will test if the type of macular neovascular membrane predicts vision and retinal recovery after pneumatic displacement in Caucasian patients aged 50 and over with submacular hemorrhage from AMD.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Azienda Sanitaria Universitaria Integrata del Trentino Academic / other |
| Locations | 1 site (Trento, Trento) |
| Trial ID | NCT07427160 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll Caucasian patients aged 50 or older who received pneumatic displacement within 36 hours for submacular hemorrhage secondary to macular neovascularization and compare outcomes across MNV subtypes (PCV, RAP, and other forms). The study will use anatomical retinal imaging and best-corrected visual acuity to measure functional and structural recovery. Cases with SMH present more than 15 days, non-MNV causes, poor imaging, prior pneumatic displacement in the study eye, or recent ocular surgery will be excluded. This single-center observational analysis at Ospedale Santa Chiara Di Trento aims to identify subtype-specific predictors of recovery in a Caucasian cohort.
Who should consider this trial
Good fit: Ideal candidates are Caucasian adults aged 50 or older with a submacular hemorrhage (≥ one papillary diameter) involving the central 3 mm of the macula from MNV who received pneumatic displacement within 36 hours of diagnosis.
Not a fit: Patients with hemorrhages present more than 15 days, hemorrhages from non-MNV causes, proliferative diabetic retinopathy or aphakia in the study eye, poor retinal imaging, prior pneumatic displacement in the study eye, or recent ocular surgery are unlikely to be eligible or benefit from the study findings.
Why it matters
Potential benefit: If successful, the findings could help doctors predict which patients are most likely to regain vision after pneumatic displacement and guide subtype-specific management decisions.
How similar studies have performed: Previous reports have suggested MNV subtype can influence outcomes after hemorrhage, particularly for PCV and RAP, but subtype-specific prognostic data following pneumatic displacement in Caucasian cohorts remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Trento, Trento
- Ospedale Santa Chiara Di Trento — Trento, Trento, Italy (Recruiting)
Study contacts
- Principal investigator: marco mazzola, MD — Azienda Sanitaria Universitaria Integrata del Trentino
- Study coordinator: marco mazzola, medical doctor
- Email: marco.mazzola@asuit.tn.it
- Phone: +393479950266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.