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

NCT ID: NCT00423189

Last Updated: 2016-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-01-31

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranibizumab only

drug - intravitreal ranibizumab

Group Type: ACTIVE_COMPARATOR

Ranibizumab (Lucentis)

Intervention Type: DRUG

as needed, one intravitreal injection of 0.50mg ranibizumab

0.5mg ranibizumab

Intervention Type: DRUG

as needed, one intravitreal injection of 0.50mg ranibizumab

40% fluence PDT/procedure

40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab

Group Type: EXPERIMENTAL

Ranibizumab (Lucentis)

Intervention Type: DRUG

as needed, one intravitreal injection of 0.50mg ranibizumab

0.5mg ranibizumab

Intervention Type: DRUG

as needed, one intravitreal injection of 0.50mg ranibizumab

20% fluence photodynamic therapy

20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab

Group Type: EXPERIMENTAL

Ranibizumab (Lucentis)

Intervention Type: DRUG

as needed, one intravitreal injection of 0.50mg ranibizumab

0.5mg ranibizumab

Intervention Type: DRUG

as needed, one intravitreal injection of 0.50mg ranibizumab

Interventions

Ranibizumab (Lucentis)

as needed, one intravitreal injection of 0.50mg ranibizumab

Intervention Type: DRUG

0.5mg ranibizumab

as needed, one intravitreal injection of 0.50mg ranibizumab

Intervention Type: DRUG

Other Intervention Names

PDT; Photodynamic Therapy; lucentis

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

David M. Brown, M.D.

OTHER

Sponsor Role: lead

Responsible Party

David M. Brown, M.D.

Director of Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David M Brown, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vitreoretinal Consultants

Locations

Vitreoretinal Consultants

Houston, Texas, United States

Countries

United States

References

Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.

Reference Type: BACKGROUND

PMID: 17021319 (View on PubMed)

Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

Reference Type: BACKGROUND

PMID: 17021318 (View on PubMed)

Michels S, Hansmann F, Geitzenauer W, Schmidt-Erfurth U. Influence of treatment parameters on selectivity of verteporfin therapy. Invest Ophthalmol Vis Sci. 2006 Jan;47(1):371-6. doi: 10.1167/iovs.05-0354.

Reference Type: BACKGROUND

PMID: 16384987 (View on PubMed)

Azab M, Boyer DS, Bressler NM, Bressler SB, Cihelkova I, Hao Y, Immonen I, Lim JI, Menchini U, Naor J, Potter MJ, Reaves A, Rosenfeld PJ, Slakter JS, Soucek P, Strong HA, Wenkstern A, Su XY, Yang YC; Visudyne in Minimally Classic Choroidal Neovascularization Study Group. Verteporfin therapy of subfoveal minimally classic choroidal neovascularization in age-related macular degeneration: 2-year results of a randomized clinical trial. Arch Ophthalmol. 2005 Apr;123(4):448-57. doi: 10.1001/archopht.123.4.448.

Reference Type: BACKGROUND

PMID: 15824216 (View on PubMed)

Related Links

http://www.houstonretina.com

GreaterHRR website

Other Identifiers

LUV

Identifier Type: -

Identifier Source: org_study_id