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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study is an evaluation of the short term effects on CNV perfusion of a same-day administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of Lucentis® (ranibizumab, 0.3 mg). An evaluation of the short term effects on CNV perfusion of this combined treatment is needed for better understanding of treatment effects.
The primary objective is to quantify the short term effects on CNV perfusion of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab. These short term effects will be assessed with visual acuity measurements and ophthalmic examinations including indocyanine green (ICG) and fluorescein angiography (FA) as well as Optical Coherence Tomography (OCT) measurements. The primary variable for this assessment is the incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography. Fluorescein and ICG angiography will be performed using a scanning laser ophthalmoscope (HRA). All angiographic studies and OCT examinations will be evaluated by the Bern Photographic Reading Center in a masked fashion. Visual acuity assessments will be performed with Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts.
A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal ranibizumab with photodynamic therapy | Drug | Intravitreal injection, photodynamic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| retinal thickness as measured by OCT over time | 24 months | |
| change of total lesion area, area of CNV and area of leakage over time as assessed by FA | 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Wolf, MD PhD | Klinik und Poliklinik fuer Augenheilkunde, Inselspital | Study Chair |
| Ute Wolf-Schnurrbusch, MD | Klinik und Polklinik fuer Augenheilkunde, Inselspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik fuer Augenheilkunde, Inselspital | Bern | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19878113 | Result | Wolf-Schnurrbusch UE, Brinkmann CK, Berger L, Wolf S. Effects of combination therapy with verteporfin photodynamic therapy and ranibizumab in patients with age-related macular degeneration. Acta Ophthalmol. 2011 Sep;89(6):585-90. doi: 10.1111/j.1755-3768.2009.01747.x. Epub 2009 Oct 30. |
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| mean change of VA from baseline over time |
| 24 months |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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