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

NCT07427160 | Recruiting DMC

• 1 other identifier: GAS.MNV
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 identify subtype-specific predictors of recovery.

Conditions

AMD - Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Central Retinal Thickness

  Baseline, 1 month, 3 months, and 6 months.

Study Arms (3)

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marco Mazzola: lead

Study Sites (1)

Ospedale Santa Chiara Di Trento

Trento, Trento, 38122, Italy

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• marco mazzola, MD

  Azienda Sanitaria Universitaria Integrata del Trentino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

marco mazzola, medical doctor

CONTACT

+393479950266; marco.mazzola@asuit.tn.it

tommaso brighenti, MD

CONTACT

+393484780821; tommaso.brighenti@asuit.tn.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MEDICAL DOCTOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (1)