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A Non- randomized, Single-Center, Open Label Case Series Study of Intravitreal Triamcinolone Acetate Injections (IVTA) Used as Adjunctive to Verteporfin Photodynamic Therapy (PDT) in the Treatment Predominantly Classic CNV Lesions Associated with Age-Related Macular Degeneration (AMD)

A Non- randomized, Single-Center, Open Label Case Series Study of Intravitreal Triamcinolone Acetate Injections (IVTA) Used as Adjunctive to Verteporfin Photodynamic Therapy (PDT) in the Treatment Predominantly Classic CNV Lesions Associated with Age-Related Macular Degeneration (AMD)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005290-30-HU
Enrollment
40
Registered
2006-06-20
Start date
2006-10-18
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Age- related macular degeneration with predominantly classic subfoveal choroidal neovascularisation MedDRA version: 8.1 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina

Interventions

Trade Name: Kenalog 40 Product Name: Kenalog 40 Pharmaceutical Form: Injection*

Sponsors

Department of Ophthalmology, Semmelweis University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged over 50 with CNV due to age-related macular degeneration with predominantly classic type of CNV at a subfoveal location (will be offered to participate in the study. Only patients otherwise amenable and willing to receive photodynamic therapy will be offered to participate in the trial. All patients must be willing to sign an informed consent and to return for follow-up visits up to one year. 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: media opacities precluding biomicroscopy, fluorescein angiography (FA) or optical coherence tomography (OCT); CNV of any origin other than AMD, such as pathologic myopia, angioid streaks, choroidal rupture, presumed ocular histoplasmosis syndrome etc., other vascular disorders such as diabetic retinopathy more severe than „moderate” NPDR, and retinal vein occlusion

Design outcomes

Primary

MeasureTime frame
Main Objective: The purpose of this study is to gather information on the safety and the synergist effect of intravitreal triamcinolone acetonide injections (IVTA), used in combination with Verteporfin photodynamic therapy.;Secondary Objective: ;Primary end point(s): • ratio of patients loosing less than 15 letters (3 lines) of visual acuity

Countries

Hungary

Outcome results

None listed

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