Status:
TERMINATED
Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD
Lead Sponsor:
Vitreous -Retina- Macula Consultants of New York
Collaborating Sponsors:
QLT Inc.
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to explore the combination of PDT with verteporfin at reduced and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal CNV of all subtype...
Detailed Description
This is a phase one study in patients with all CNV lesion subtypes who are naïve to previous treatment. Lesions must have blood as a primary component (i.e., contain more than 50% blood). Patients wil...
Eligibility Criteria
Inclusion
- Patients are men or women of age 50 or older.
- Patients diagnosed with subfoveal CNV due to AMD with lesion size ≤6 DA.
- Patients have not received previous treatment for subfoveal CNV, in the study eye.
- Patients with visual acuities at baseline between 20/40 and 20/320, as evaluated on ETDRS scale.
- Fluorescein Angiography showing any type of subfoveal CNV at baseline with \>50% blood component of total lesion area.
Exclusion
- Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
- Patients with history of glaucoma requiring treatment, or are currently on antihypertensive treatment for elevated intraocular pressure.
- Women of childbearing potential must not be pregnant of lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control.
- Patients who have had treatment for CNV in the study eye with photodynamic therapy (PDT), transpupillary thermotherapy (TTT), or other local treatment (e.g. submacular surgery, intravitreal triamcinolone, intra-ocular antiangiogenic agents). Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
- Subject's currently who have been involved in any experimental procedure within the last 12 weeks.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00403442
Start Date
September 1 2006
Last Update
July 30 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vitreous Retina Macula Consultants of New York, P.C.
New York, New York, United States, 10022