Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT00455871 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| QLT Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the benefits, if any, of combination therapy with Lucentis plus reduced fluence photodynamic therapy with Visudyne.
The study will have two treatment groups. Each group will receive intravitreal injections (injection of medication in the jelly-like part of the back of the eye). One group (Group1) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by reduced fluence Photodynamic Therapy (PDT) with Visudyne ® 1-2 weeks later. The other group (Group 2) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by Photodynamic Therapy with Visudyne on the same day. patients will be assigned at random to receive one of the two treatments arms in the study. The dose received at the first injection will be the same dose received throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis plus Reduced Fluence PDT same day | Active Comparator |
| |
| Lucentis plus reduced fluence PDT 1-2 weeks later | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reduced fluence photodynamic therapy with Visudyne | Drug | reduced fluence photodynamic therapy with visudyne |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of the combination therapy | 12 months and 24 months | |
| To assess efficacy of the two timing regimens | 12 months and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the number of Lucentis injections and the number of PDT treatments required during the study | 12 months and 24 months |
Not provided
Inclusion Criteria:
Ability to give informed consent
Treatment- naïve patients with active, subfoveal, exudative AMD
Patients with visual acuity of 20/40-20/320 in the study eye
Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size Total area of lesion components other that CNV must be less than 50% of the total lesion size
The lesion must be < 5400microns in greatest linear dimension (GLD)
Lesion size < 10 DA
Occult with no classic CNV lesions must have presumed recent disease progression:
Previous treatment for CNV with anti-VEGF agents, intraocular steroids and/or Photodynamic therapy with Visudyne® in the study eye
Geographic atrophy or fibrosis in the study eye
Intraocular surgery within 6 weeks of enrollment
Subretinal hemorrhage > 50% of the total lesion
Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
Patients with severe disciform scarring.
Inability to make study visits
Advanced glaucoma
Allergies to porfins or a known hypersensitivity to any component of Visudyne®
Patients with porphyria
Pregnancy or lactation
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pamela A Light, CCRC | Contact | 314-367-1278 | 2287 | bristudies@barnesretinainstitute.com |
| Rhonda F Weeks | Contact | 314-367-1278 | 2240 | bristudies@barnesretinainstitute.com |
| Name | Affiliation | Role |
|---|---|---|
| Gaurav K. Shah, MD | Barnes Retina Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Retina Institute | Recruiting | St Louis | Missouri | 63110 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lucentis | Drug | Lucentis intravitreal injection |
|
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077362 | Verteporfin |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided