Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration
Stopped early · Phase 4
Conditions studied: Age-Related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT00423189
- Run by
- David M. Brown, M.D.
- People needed
- 7
- Starts
- 2007-01-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2016-03-04
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Vitreoretinal Consultants — Houston, Texas, United States
Full record on ClinicalTrials.gov
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