Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
15 participants
OBSERVATIONAL
2008-01-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lucentis (PRN group)
No interventions assigned to this group
Lucentis (3 Injections over three months)
No interventions assigned to this group
PDT (Reduced Fluence) and Lucentis
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
1. Blood associated with the lesion at baseline
2. Loss of visual acuity in the previous 3 months: a: \> 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
3. \> 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months
Exclusion Criteria
* Geographic atrophy in the study eye
* Tear (rip) of the retinal pigment epithelium
* Presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion
* Intraocular surgery within 6 weeks of enrollment
* Active or history of ocular inflammation or infection in the study eye within the last 30 days
* Subretinal hemorrhage \> 50% of the total lesion
* History of submacular surgery, or transpupillary thermotherapy in the study eye
* Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
* Patients with severe disciform scarring
* History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery within 60 days prior to screening
* History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening
* Inability to make study visits
* Advanced glaucoma, uncontrolled glaucoma in the study eye (defined as intraocular pressure, IOP ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication)
* Allergies to porphyrins or a known hypersensitivity to any component of Visudyne®
* Patients with porphyria
* Pregnancy or lactation
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis
INDUSTRY
Barnes Retina Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rhonda Weeks
Gaurav K. Shah, MD
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CBPD952AUS18T
Identifier Type: -
Identifier Source: org_study_id