classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).
Conditions
Interventions
Product Name: Photrex (Rostaporfin)
Product Code: SnET2
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: Rostaporfin
CAS Number: 284041-10-7
Other descriptive name: Tin ethyl etiopurpur
Sponsors
Miravant Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females, 50 years of age or older 2. Able to understand and give written informed consent prior to performing any study related procedures. 3. CNV consistent with AMD in study eye. 4. At screening the active CNV lesions in the study eye: • Must have at least one subfoveal CNV membrane secondary to AMD that can be clearly demonstrated by FA. • Area of lesion components must not exceed 3 DA. Here, lesion components are defined as CNV plus adjacent blocked fluorescence and blood that may obscure underlying CNV. Furthermore, subretinal fibrous tissue is considered a lesion component. Determination of lesion size and composition will be made by the Fundus Photograph Reading Center (FPRC), Madison, WI. • Must not be developing an early disciform scar that is greater than 25% of the area of the lesion as judged from clinical examination and/or color photographs (as determined by the FPRC, Madison, WI). In each subject only one lesion in one study eye may be treated with rostaporfin- PDT. Selection of the study eye is at the discretion of the investigator. 5. At screening the purely occult CNV lesions in the study eye must exhibit evidence of SSRD or PED, with the size of SSRD or PED being at least 2 DA (as determined by the FPRC, Madison, WI). 6. Must have a best-corrected Screening visual acuity score of 34 – 70 ETDRS (Early TreatmentDiabetic Retinopathy Study) letters (Snellen-equivalent approximately 20/200 to 20/40). 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: 1. Previous laser treatment for subfoveal macular disease in the study eye. 2. Anterior segment abnormalities including those of the cornea, anterior chamber, iris, or lens that would preclude adequate examination of the ocular fundus or obtaining good quality images. The pupil of the study eye cannot be dilated to = 4 mm. 3. Ocular surgery (excluding yttrium aluminum garnet [YAG] capsulotomy) in the study eye within the past three months. 4. Glaucoma of any type, in the study eye, if the cup/disc ratio is = 0.8 or if field loss is advanced (= 10 decibel decrease in the automatic perimeter in the 30-degree central visual field). 5. Ocular disease of any type in the study eye that could independently affect VA of the study eye, such as diabetic retinopathy (>10 microaneurysms or small retinal hemorrhages), high axial myopia (>-8.00 diopters), pattern dystrophy, epiretinal membranes, nevus associated with neovascular membrane, macular hole with or without neovascular membranes, nystagmus, branch vein occlusion or RPE abnormalities other than AMD. 6. Dense submacular hemorrhage = 50% of study lesion area (a pseudopod of blood extending from the lesion that is so narrow as to be unlikely to obscure underlying CNV is excluded when determining lesion area). 7. CNV from other disease, i.e., high myopia (axial length >8 diopters), angioid streaks, pseudoxanthoma elasticum, presumed ocular histoplasmosis or idiopathic CNV. 8. Pigmentation of the macular or paramacular region from the prior use of any maculaaffecting drugs such as hydroxychloroquine, chloroquine, thioridazine, other phenothiazine derivatives, or any use of these drugs within the last 12 months. 9. Use of an investigational drug or other investigational therapy within 30 days prior to study drug dosing. 10. Intravitreal injections administered in the study eye within 6 months prior to study entry. 11. Use of any systemic or topical PDT agents. 12. Use of Thalidomide for treatment of AMD or other diseases. 13. Known allergic or hypersensitivity reactions to light, fluorescein, egg proteins, or eggyolk. 14. History of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum. 15. Known disorder of lipoprotein metabolism or clearance (cholesterol> 400 mg/dl, and/or triglycerides > 500 mg/dl). 16. Gamma glutamyl transferase (GGT) at study entry = 2.5 times upper limit of normal. 17. Compromised hepatic function within 14 days of therapy (i.e., bilirubin >1.5 times the upper limit of normal, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of normal levels). 18. Compromised cardiovascular function (i.e., myocardial infarction (MI) within the past 6 months, clinically significant arrhythmia, or clinically significant conduction abnormalities). 19. Presence of significant coronary artery disease that requires ongoing coumarin anticoagulants therapy, which include warfarin and dicumarol. (Aspirin antithrombotic therapy will not exclude subjects.) 20. Significant pulmonary insufficiency reported within the last 12 weeks. 21. The presence of any disease that would make survival for the study period unlikely or that severely limits the study subjects’s daily activity, or is likely to limit activity within 2 years, to the extent that the study subjects would be unable to return for regular follow-up visits. 22. Pregnancy or a positive urine pregnancy test result within 7 days of treatment, or nur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy and safety of rostaporfin (Photrex™; formerly known as SnET2) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).;Secondary Objective: ;Primary end point(s): The primary efficacy variable will be the proportion of subjects losing fewer than 15 letters (<3 lines of visual acuity loss) compared to baseline, as measured on an ETDRS chart. This efficacy variable will be examined at two time points, 51 weeks and 103 weeks after the start of treatment. Demonstration of statistically significant benefit at the Week 51 endpoint will satisfy the efficacy requirements for market approval. If significant benefit is not demonstrated at Week 51 , the success rate at Week 103 will be tested and, if significance is demonstrated, this data set will satisfy the efficacy requirements for approval. | — |
Countries
Czech Republic
Outcome results
None listed