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Phase III clinical trial multicenter randomized for the evaluation of the safety and efficacy of the combined treatment of intravitreal triamcinolone and photodynamic therapy versus intravitreal Bevacizumab and photodynamic therapy versus intravitreal Bevacizumab for the treatment of neo-vascular maculopathy type retinal angiomatous prolipheration (RAP). - ND

Phase III clinical trial multicenter randomized for the evaluation of the safety and efficacy of the combined treatment of intravitreal triamcinolone and photodynamic therapy versus intravitreal Bevacizumab and photodynamic therapy versus intravitreal Bevacizumab for the treatment of neo-vascular maculopathy type retinal angiomatous prolipheration (RAP). - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001468-34-IT
Enrollment
Unknown
Registered
2009-03-23
Start date
2008-11-20
Completion date
Unknown
Last updated
2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroideal neo-vascularization type RAP. MedDRA version: 9.1 Level: SOC Classification code 10015919

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: Bevacizumab Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: .05- Pharmaceutical Form: Solution fo

Sponsors

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Signed informed consent. Age > 50 year. RAP stage II and III. BCVA with ETDRS between 20/40 and 20/320. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Decompensated blood hypertension. Thromboembolic events within 6 months, including TIA, cerebral stroke, and myocardial infarction. Impossibility to document the lesion via FA, ICG, angiography, color photos of fundus oculi,OCT. Any other condition that could compromize visual acuity.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: None.;Primary end point(s): Stabilization of the lesion size.;Main Objective: To evaluate the effectiveness of the combined treatment of intravitreal triamcinolone and photodynamic therapy versus intravitreal Bevacizumab and photodynamic therapy versus intravitreal Bevacizumab in the treatment of RAP.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026