Treatment of retinal angiomatous proliferation lesions due to age-related macular degeneration with ranibizumab (Lucentis®) and photodynamic therapy with verteporfin (Visudyne®) - LUPRA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004367-57-AT

Enrollment

Registered

2008-04-07

Start date

2008-05-14

Completion date

Unknown

Last updated

2016-11-07

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

Conditions

Subtype of neovascular age-related macular degeneration, so called retinal angiomatous proliferation or RAP. MedDRA version: 8.1 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina

Interventions

Trade Name: Lucentis Product Name: Lucentis Pharmaceutical Form: Concentrate for solution for injection Trade Name: Visudyne Pharmaceutical Form: Solution for infusion INN or Proposed INN: VERTEPORFI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who at baseline • have a best corrected visual acuity (BCVA) letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart measured at 4 meters or Snellen equivalent • have a RAP lesion in the study eye with the following characteristics as determined by fluorescein and indocyanine green angiography: 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: • any other form of AMD or of neovascular maculopathy, including pathologic myopia, angioid streaks, infectious or inflammatory chorioretinal diseases, ocular tumors, prior radiation therapy, hereditary disorders, or trauma. • Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes • Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy

Design outcomes

Primary

Measure	Time frame
Main Objective: • This case-series is designed to evaluate the safety and efficacy of intravitreal ranibizumab (Lucentis®) used in combination with verteporfin photodynamic therapy (Visudyne®) in the treatment of sub- and juxtafoveal retinal angiomatous proliferations (RAP) secondary to AMD.;Secondary Objective: • mean change from baseline in best corrected visual acuity (BCVA) at months 6 • proportion of patients who gain = 5, 10, 15 letters of BCVA from baseline at months 6, and 12 • proportion of patients who lose less than 15 letters of BCVA from baseline at months 6 and 12 • mean change from baseline in total size of lesion and total size of CNV at 3, 6, and 12 months on FA • change in area of leakage at 3, 6 and 12 months • proportion of patients with disappearence of RAP lesions in the early phase and the hot spots in the late phase of ICGA at 3, 6, and 12 months ;Primary end point(s): Evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab	—

Measure

Time frame

Main Objective: • This case-series is designed to evaluate the safety and efficacy of intravitreal ranibizumab (Lucentis®) used in combination with verteporfin photodynamic therapy (Visudyne®) in the treatment of sub- and juxtafoveal retinal angiomatous proliferations (RAP) secondary to AMD.;Secondary Objective: • mean change from baseline in best corrected visual acuity (BCVA) at months 6 • proportion of patients who gain = 5, 10, 15 letters of BCVA from baseline at months 6, and 12 • proportion of patients who lose less than 15 letters of BCVA from baseline at months 6 and 12 • mean change from baseline in total size of lesion and total size of CNV at 3, 6, and 12 months on FA • change in area of leakage at 3, 6 and 12 months • proportion of patients with disappearence of RAP lesions in the early phase and the hot spots in the late phase of ICGA at 3, 6, and 12 months ;Primary end point(s): Evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab

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Countries

Austria

Outcome results

None listed

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