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NCT Number: NCT07427160

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.

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Key information

Conditions

AMD - Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Santa Chiara Di Trento

Trento, 38122, Italy

Location status: Recruiting

Location contact

marco mazzola, MD

CONTACT

[email protected]

+39479950266

marco mazzola, MD

PRINCIPAL_INVESTIGATOR

tommaso brighenti, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Change in Central Retinal Thickness

    Time frame: Baseline, 1 month, 3 months, and 6 months.

    Measurement of retinal thickness (in microns) using Spectralis HRA+OCT to evaluate the anatomical response to treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

marco mazzola, medical doctor

CONTACT

[email protected]

+393479950266

tommaso brighenti, MD

CONTACT

[email protected]

+393484780821

Sponsors and collaborators

Lead sponsor

Marco Mazzola

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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