Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration

Phase 4

Terminated

Conditions: Age-Related Macular Degeneration

Interventions: Drug: Ranibizumab (Lucentis)
Drug: 0.5mg ranibizumab

Registration Number: NCT00423189

Lead Sponsor: David M. Brown, M.D.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

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
Participation in another simultaneous medical investigator or trial
Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment or macular hole.
Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period
Aphakia or absence of the posterior capsule in the study eye
Previous violation of the posterior capsule is also excluded unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
History of idiopathic or autoimmune uveitis in either eye
Significant structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s)
Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT
Ocular inflammation (including trace or above) in the study eye
Uncontrolled glaucoma (defined as intraocular pressure ≥30 mm Hg despite treatment with anti- medications) or previous filtration surgery in the study eye
Infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection
Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia (For patients who have had refractive or cataract surgery in the study eye, pre-operative spherical equivalent refractive error of more than -8 diopters myopia is not allowed)

Systemic Conditions

Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period
Uncontrolled diabetes mellitus
Renal failure requiring dialysis or renal transplant
Premenopausal women not using adequate contraception
Previous participation in other studies of investigational drugs (excluding vitamins and minerals) within 3 months preceding Day 0
History of other disease, metabolic dysfunction, physical examination finding, or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications
INR ≥ 3.0 (e.g. due to current treatment with warfarin). The use of aspirin is not an exclusion.

Other

History of allergy to fluorescein, not amenable to treatment
History of allergy to shellfish
History of allergy to intravenous iodine
History of allergy to indocyanine green
Inability to obtain fundus photographs or angiograms of sufficient quality to be analyzed and graded by the central reading center
Inability to comply with study or follow up procedures
History of allergy to humanized antibodies or any component of the ranibizumab formulation

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40% fluence PDT/procedure	Ranibizumab (Lucentis)	40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
40% fluence PDT/procedure	0.5mg ranibizumab	40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
20% fluence photodynamic therapy	Ranibizumab (Lucentis)	20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
20% fluence photodynamic therapy	0.5mg ranibizumab	20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Ranibizumab only	0.5mg ranibizumab	drug - intravitreal ranibizumab
Ranibizumab only	Ranibizumab (Lucentis)	drug - intravitreal ranibizumab

Primary Outcome Measures

Name	Time	Method
Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)	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 Outcome Measures

Name	Time	Method
Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months	1 Year	Number of intravitreal injections with ranibizumab needed by patients at 12 months was not determined due to lack of efficacy.
OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)	1 Year	OCT 3 macular thickness improvement at Baseline-1month, 2months, 3months, 6months \&12 months was not determined due to lack of efficacy.
Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months	1 Year	Choroidal perfusion as assessed by ICG angiography at 1, 2, 3, 6, and 12 months was not determined due to lack of efficacy
Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab	1 Year	Safety of combination therapy with verteporfin PDT and ITV ranibizumab was not determined due to lack of efficacy.