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Verteporfin photodynamic therapy · 2 trials · 2 indications
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.
The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.
| Arm | Type | Description |
|---|---|---|
| Verteporfin With Standard Fluence Rate Plus Ranibizumab | EXPERIMENTAL | Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria. |
| Ranibizumab Monotherapy | ACTIVE_COMPARATOR | Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). |
| Verteporfin With Reduced Fluence Rate Plus Ranibizumab | EXPERIMENTAL | Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria. |
| Verteporfin and Triamcinolone 1 mg | EXPERIMENTAL | Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy. |
| Verteporfin and Triamcinolone 4 mg | EXPERIMENTAL | Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy. |
| Verteporfin and Pegaptanib | ACTIVE_COMPARATOR | Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy. |
| Name | Type | Description |
|---|---|---|
| Verteporfin Photodynamic Therapy | DRUG | After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 (Standard Fluence rate) or 25 J/cm\^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion. |
| Ranibizumab | DRUG | Ranibizumab 0.5 mg administered as an intravitreal injection. |
| Verteporfin Placebo | DRUG | To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion. |
| Ranibizumab Placebo | DRUG | To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm. |
| Pegaptanib | DRUG | Pegaptanib sodium 0.3 mg administered by intravitreal injection. |
| Triamcinolone acetonide | DRUG | Triamcinolone acetonide administered by intravitreal injection. |
Inclusion Criteria: * Subjects of either gender age 50 years or older * Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) Exclusion Criteria: * Choroidal neovascularization due to causes other than AMD * Prior treatment for neovascular AMD in the study eye...
Verteporfin photodynamic therapy is used for macular degeneration, specifically for choroidal neovascularization, a condition involving abnormal blood vessel growth under the retina. It is an ophthalmology treatment being developed by Novartis AG (NVS) and is currently in Phase 3 clinical development.
Verteporfin photodynamic therapy is a small molecule modality that works through photodynamic therapy, where the drug is activated by light to target abnormal blood vessels in the eye. It is being studied for the treatment of macular degeneration with choroidal neovascularization.
Verteporfin photodynamic therapy is developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The therapy is currently in Phase 3 clinical trials for macular degeneration.
Verteporfin photodynamic therapy is in Phase 3 clinical development. It is an investigational therapy for macular degeneration and is not yet approved. Two Phase 3 trials have been completed, with a total enrollment of 432 patients.
Verteporfin photodynamic therapy has two completed Phase 3 trials. NCT00242580 studied it in combination with triamcinolone acetonide or pegaptanib in 111 patients. NCT00436553 compared it with ranibizumab in 321 patients. Both trials involved patients with subfoveal choroidal neovascularization.
Verteporfin photodynamic therapy is a treatment that uses the drug verteporfin, which is also known by the brand name Visudyne. The therapy involves light activation of the drug to treat macular degeneration with choroidal neovascularization.