Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages

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 Overview

• Status: Recruiting
• Conditions: AMD - Age-Related Macular Degeneration

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: marco mazzola, medical doctor; Phone Number: +393479950266; Email: marco.mazzola@asuit.tn.it
• Study Contact Backup: Name: tommaso brighenti, MD; Phone Number: +393484780821; Email: tommaso.brighenti@asuit.tn.it

Study Locations

• Italy
  • Trento
    • Trento, Trento, Italy, 38122
      • Recruiting
      • Ospedale Santa Chiara Di Trento
      • Contact: marco mazzola, MD; Phone Number: +39479950266; Email: marco.mazzola@asuit.tn.it
      • Contact: tommaso brighenti, MD; Email: tommaso.brighenti@asuit.tn.it
      • Principal Investigator: marco mazzola, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline and 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Central Retinal Thickness	Measurement of retinal thickness (in microns) using Spectralis HRA+OCT to evaluate the anatomical response to treatment.	Baseline, 1 month, 3 months, and 6 months.

Collaborators and Investigators

• Sponsor: Marco Mazzola
• Investigators: Principal Investigator: marco mazzola, MD, Azienda sanitaria universitaria integrata del Trentino

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration
• Other Study ID Numbers: GAS.MNV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No