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

ConditionAMD - Age-Related Macular Degeneration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorMarco Mazzola

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 3 trial groups
Group A: PCV
Group B: RAP
Group C: Other MNV

Trial outcomes

Primary outcomes

1

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

Time frame
5-8 days post-treatment
2

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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marco Mazzola

Lead sponsor

Azienda Sanitaria Universitaria Integrata del Trentino

Sponsor institution

Source ClinicalTrials.gov
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