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

February 5, 2016 updated by: David M. Brown, M.D.

Lucentis Utilizing Visudyne (LUV Trial)-- Reduced Fluence Photodynamic Therapy With Visudyne Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Vitreoretinal Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ranibizumab only
drug - intravitreal ranibizumab
Drug: Ranibizumab (Lucentis)
as needed, one intravitreal injection of 0.50mg ranibizumab
Other Names:
  • PDT
  • Photodynamic Therapy
Drug: 0.5mg ranibizumab
as needed, one intravitreal injection of 0.50mg ranibizumab
Other Names:
  • lucentis
EXPERIMENTAL: 40% fluence PDT/procedure
40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Drug: Ranibizumab (Lucentis)
as needed, one intravitreal injection of 0.50mg ranibizumab
Other Names:
  • PDT
  • Photodynamic Therapy
Drug: 0.5mg ranibizumab
as needed, one intravitreal injection of 0.50mg ranibizumab
Other Names:
  • lucentis
EXPERIMENTAL: 20% fluence photodynamic therapy
20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Drug: Ranibizumab (Lucentis)
as needed, one intravitreal injection of 0.50mg ranibizumab
Other Names:
  • PDT
  • Photodynamic Therapy
Drug: 0.5mg ranibizumab
as needed, one intravitreal injection of 0.50mg ranibizumab
Other Names:
  • lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David M. Brown, M.D.

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: David M Brown, M.D., Vitreoretinal Consultants

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

January 16, 2007

First Submitted That Met QC Criteria

January 16, 2007

First Posted (ESTIMATE)

January 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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