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Status unknownNCT02799992Updated Jun 15, 2016

Pseudo-PDT in Central Serous Chorioretinopathy

An interventional study of 689 nm Laser Treatment of the Macula and Half Dose Photodynamic Therapy in Chronic Central Serous Chorioretinopathy, sponsored by Università degli Studi di Brescia. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-15.

Sponsored by Università degli Studi di Brescia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients, characterized by serous retinal detachment in the macular region. We evaluated half-dose verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.

Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography findings were compared between groups.

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Conditions studied

  • Chronic Central Serous Chorioretinopathy
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In context

Central Serous Chorioretinopathy

86 studies on the registry are indexed under Central Serous Chorioretinopathy; 13 are open to participants now.

This study's planned enrollment of 22 is below the median of 30 across 62 interventional studies indexed under Central Serous Chorioretinopathy.

Browse Central Serous Chorioretinopathy studies →

Lead sponsor

Università degli Studi di Brescia is the lead sponsor of 46 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age ≥18 years;
  • patients with best-corrected visual acuity (BCVA) of 20/200 or better;
  • presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment involving the fovea on optical coherence tomography (OCT);
  • presence of active angiographic leakage in fluorescein angiography caused by CSC and no other diseases, and abnormal dilated choroidal vasculature and other features in indocyanine green angiography (ICGA) consistent with the diagnosis of CSC.

Exclusion criteria

Exclusion Criteria:

  • any previous treatment for CSC;
  • evidence of choroidal neovascularization or other maculopathy on fundus examination.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Active comparator
    Half Dose Photodynamic Therapy

    Half Dose Photodynamic Therapy The safety enhanced PDT protocol for CSC was performed using half the normal dose of verteporfin (Visudyne, Novartis Pharma, Switzerland), which is 3 mg/m2 verteporfin

    Procedure: Half Dose Photodynamic Therapy

  • Experimental
    689 nm Laser Treatment

    A 689 nm laser treatment delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds was performed. No verteporfin or other drugs were administered to the patients.

    Procedure: 689 nm Laser Treatment of the Macula

Interventions

  • Procedure689 nm Laser Treatment of the Macula
  • ProcedureHalf Dose Photodynamic Therapy
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What researchers measure

Primary outcomes

  1. Best-corrected Visual Acuity (LogMAR)

    Measured with ETDRS chart

    Time frame: 6 months

  2. Central Retinal Thickness (micron)

    Measured with OCT

    Time frame: 6 months

  3. Subfoveal Choroidal Thickness (micron)

    Measured with OCT

    Time frame: 6 months

Secondary outcomes

  1. Ellipsoid Zone Recovery (integrity of IS/OS line)

    As visible with OCT scans

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02799992
Lead sponsor
Università degli Studi di Brescia
Responsible party
Andrea Russo (MD, PhD Candidate, Università degli Studi di Brescia) — Principal investigator
First posted
Jun 15, 2016
Start date
Jun 2016
Primary completion
Sep 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Jun 15, 2016

Study contacts

Andrea Russo, MD, PhD
Contact
dott.andrea.russo@gmail.com
+390303995308
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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