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Age-Related Macular DegenerationPhase 4NCT00423189

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

A Phase 4 study testing Ranibizumab (Lucentis) and 0.5mg ranibizumab in people with Age-Related Macular Degeneration, run by David M. Brown, M.D. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
Ranibizumab (Lucentis) and 0.5mg ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
Jan 2007to Jan 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 38Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vitreoretinal Consultants

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Ranibizumab (Lucentis), 0.5mg ranibizumab
Keywords
LUV, Lucentis, Visudyne, PDT, AMD, ARMD, Age, Related, Macular, Degeneration
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ranibizumab (Lucentis)Drug

    Also called PDT, Photodynamic Therapy

    as needed, one intravitreal injection of 0.50mg ranibizumab

  • 0.5mg ranibizumabDrug

    Also called lucentis

    as needed, one intravitreal injection of 0.50mg ranibizumab

Study groups in NCT00423189
Study groupRoleWhat they receive
Ranibizumab onlyActive comparatordrug - intravitreal ranibizumab
Receives: Drug: Ranibizumab (Lucentis); Drug: 0.5mg ranibizumab
40% fluence PDT/procedureExperimental40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Receives: Drug: Ranibizumab (Lucentis); Drug: 0.5mg ranibizumab
20% fluence photodynamic therapyExperimental20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Receives: Drug: Ranibizumab (Lucentis); Drug: 0.5mg ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)

    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.

    Measured: 1 Year

Secondary outcomes (4)

  1. Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months

    Number of intravitreal injections with ranibizumab needed by patients at 12 months was not determined due to lack of efficacy.

    Measured: 1 Year

  2. OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)

    OCT 3 macular thickness improvement at Baseline-1month, 2months, 3months, 6months \&12 months was not determined due to lack of efficacy.

    Measured: 1 Year

  3. Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months

    Choroidal perfusion as assessed by ICG angiography at 1, 2, 3, 6, and 12 months was not determined due to lack of efficacy

    Measured: 1 Year

  4. Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab

    Safety of combination therapy with verteporfin PDT and ITV ranibizumab was not determined due to lack of efficacy.

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2009
  4. Study completionJan 2009

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423189
Sponsor's protocol ID
LUV
Status last verified
Feb 2016
First submitted
16 Jan 2007
Last updated
4 Mar 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17021319

  • 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.

    PubMed 17021318

  • 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.

    PubMed 16384987

  • 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.

    PubMed 15824216

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ranibizumab (Lucentis) and 0.5mg ranibizumab in people with Age-Related Macular Degeneration, run by David M. Brown, M.D. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00423189, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.

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