Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | May 2007 |
| End Date: | June 2009 |
| Contact: | Scott J Westhouse, DO |
| Email: | westhouses@hotmail.com |
| Phone: | 918-747-7799 |
A Prospective Pilot Study of Reduced Fluence Photodynamic Therapy With Visudyne® (Verteporfin) in Combination With Lucentis™ (Ranibizumab) for the Treatment of Age-Related Macular Degeneration
In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced
fluence PDT combination therapy with ranibizumab. The researchers hope to gain information
regarding the use of reduced fluence PDT combination therapy. The information gained from
this pilot study may prompt further definitive studies comparing the safety and efficacy of
both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and
ranibizumab monotherapy.
The study will compare the use of combination therapy with ranibizumab and verteporfin PDT
to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All
patients will receive three consecutive monthly treatments with ranibizumab. Patients will
be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only
ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced
fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also
receive one treatment with standard fluence verteporfin PDT. All patients will also be
evaluated for possible retreatment with ranibizumab and verteporfin PDT according to
established criteria. Thirty patients will be recruited from one U.S. sites. Randomization
will occur at the time of entry into the study. Follow-up will continue until month 12 (from
day 0) in all subjects.
Inclusion Criteria:
1. Male or Female Patients > 50 years of age.
2. Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.
3. Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic
Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.
4. If both eyes are eligible, only one eye will be evaluated in the study. The eye with
lesser visual acuity will be selected as the study eye.
5. Patients must be able and willing to provide written informed consent.
Exclusion Criteria:
1. Patients receiving prior treatment in the study eye with verteporfin, any focal laser
photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic
medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.
2. Neovascular membrane from any other retinal disease such as myopic degeneration,
histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory
disease.
3. Choroidal neovascular membrane greater than 9 disc diameters in size.
4. Previous posterior vitrectomy in the study eye.
5. Concurrent disease in the study eye that could compromise visual acuity or require
medical or surgical intervention during the study period.
6. Pregnant women or premenopausal women not using adequate contraception.
7. History of allergy to fluorescein, Visudyne, Lucentis.
8. Inability to comply with study or follow up procedures.
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