Actively Recruiting
Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages
Led by Marco Mazzola · Updated on 2026-02-23
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the role of different types of macular neovascularization (MNV) in patients treated with pneumatic displacement for submacular hemorrhage (SMH). The study focuses on patients with SMH secondary to age-related macular degeneration (AMD), specifically comparing outcomes among subtypes such as Polypoidal Choroidal Vasculopathy (PCV), Retinal Angiomatous Proliferation (RAP), and other forms of MNV in a Caucasian patient group. The goal is to identify subtype-specific predictors of recovery in terms of anatomy and vision. Participants receive pneumatic displacement treatment within 36 hours of SMH diagnosis. The study groups include patients classified by MNV subtype: PCV, RAP, and other MNV types. The treatment involves a procedure aimed at displacing the hemorrhage affecting the macula. Patients are observed without experimental drug interventions, as this is an observational study. During the study, researchers will monitor anatomical success of the pneumatic displacement within 5 to 8 days after treatment and measure changes in best-corrected visual acuity (BCVA) from baseline to 6 months. They will also track changes in central retinal thickness at baseline, 1 month, 3 months, and 6 months. Participants will be followed for at least 6 months after the procedure to assess recovery and treatment outcomes.
CONDITIONS
Brief Title
Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment performed within 36 hours of diagnosis
Participants undergo pneumatic displacement treatment for submacular hemorrhage secondary to macular neovascularization.
1 treatment visit (in-person)
Duration - 6 months
Participants are monitored for anatomical success and changes in visual acuity and retinal thickness after treatment.
Visits at 5 to 8 days post-treatment, baseline, 1 month, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
Ospedale Santa Chiara Di Trento
Trento, Trento, Italy, 38122
Actively Recruiting
Research Team
M
marco mazzola, medical doctor
T
tommaso brighenti, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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