Clinical trial NCT00473642: Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-Related Maculopathy
Choroidal Neovascularization
Keywords: Ranibizumab
Lucentis
Verteporfin
Visudyne
Photodynamic therapy
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-05-15
Enrollment: 31
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months
timeFrame: 12 months
measure: Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol
timeFrame: 12 months
Secondary outcomes:
measure: Time to First Retreatment After Loading Doses
timeFrame: 12 months
measure: Average Number of PDT Retreatments Over 12 Months
timeFrame: 12 months
measure: Central Macular Thickness Reduction on OCT
timeFrame: 12 months
measure: Average Number of Ranibizumab Retreatments Over 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Eagle Mountain Vision
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Medical Center
name: Scott J Westhouse, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma State University Medical Center
name: Raymond Townsend, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma State University Medical Center
name: John Saurino, DO
role: PRINCIPAL_INVESTIGATOR
References: