Lucentis Utilizing Visudyne (LUV Trial)-- Reduced Fluence Photodynamic Therapy With Visudyne Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration
Overview
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- David M. Brown, M.D.
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)
Overview
Brief Summary
The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD.
Detailed Description
The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD. Patients will be randomized to one of three groups. All patients will receive three consecutive monthly treatments with ITV ranibizumab. Patients randomized to group I will receive only ITV ranibizumab. Patients randomized to group II will also receive one treatment with reduced fluence (20% fluence) verteporfin PDT at day 0. Patients randomized to group III will also receive one treatment with reduced fluence (40% fluence) vPDT. All patients will also be evaluated for possible retreatment with ranibizumab according to established criteria. Thirty patients (ten per group) will be recruited from one U.S. sites in a 6-month period. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age \> 55 years
- •Subfoveal neovascular membrane confirmed by fluorescein angiography and or ICG
- •Visual acuity not better than 20/32 and not worse than 20/320 by ETDRS refraction
Exclusion Criteria
- •Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery)
- •Intracapsular cataract extraction (posterior capsule needs to be present)
- •Previous treatment with ranibizumab
- •Previous treatment with pegaptanib
- •Previous treatment with ITV triamcinolone
- •Any previous treatment with photodynamic therapy
- •Previous history of retinal detachment in study eye
- •Any previous radiation treatments to head/ neck
- •Significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12 month study
- •Prior enrollment in any study for AMD in the study eye
Arms & Interventions
40% fluence PDT/procedure
40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Intervention: 0.5mg ranibizumab (Drug)
Ranibizumab only
drug - intravitreal ranibizumab
Intervention: Ranibizumab (Lucentis) (Drug)
Ranibizumab only
drug - intravitreal ranibizumab
Intervention: 0.5mg ranibizumab (Drug)
40% fluence PDT/procedure
40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Intervention: Ranibizumab (Lucentis) (Drug)
20% fluence photodynamic therapy
20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Intervention: Ranibizumab (Lucentis) (Drug)
20% fluence photodynamic therapy
20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Intervention: 0.5mg ranibizumab (Drug)
Outcomes
Primary Outcomes
Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)
Time Frame: 1 Year
Visual Acuity was measured by ETDRS by certified refractionists in certified lanes at 12 months. Visual Acuity was not measured by ETDRS at 6 months.
Secondary Outcomes
- Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months(1 Year)
- OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)(1 Year)
- Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months(1 Year)
- Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab(1 Year)
Investigators
David M. Brown, M.D.
Director of Research
Greater Houston Retina Research