Use of Spectral OCT in Combination Therapy (Spectral OCT)
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This study will investigate the safety and efficacy of treatment of choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) with a combination of ranibizumab (Lucentis) and verteporfin PDT (Visudyne), as compared with ranibizumab monotherapy.
This pilot study observed anatomical measures which are currently not defined since the new technology is unclear in regards to what changes are seen at the level of the RPE and photoreceptors. [ Time Frame: 3 months ]
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Barnes Retina Institute clinic
Ability to give informed consent
Patients with visual acuity of 20/40-20/320 in the study eye
Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size.
Total area of lesion components other that CNV must be less than 50% of the total lesion size.
The lesion must be < 5400microns in greatest linear dimension (GLD).
Lesion size < 10 DA
Occult with no classic CNV lesions must have presumed recent disease progression:
Blood associated with the lesion at baseline
Loss of visual acuity in the previous 3 months: a: > 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
> 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months
Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia (-8 or more with evidence of posterior segment abnormalities consistent with pathologic myopia), or CNV secondary to causes other than AMD
Geographic atrophy in the study eye
Tear (rip) of the retinal pigment epithelium
Presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion
Intraocular surgery within 6 weeks of enrollment
Active or history of ocular inflammation or infection in the study eye within the last 30 days
Subretinal hemorrhage > 50% of the total lesion
History of submacular surgery, or transpupillary thermotherapy in the study eye
Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
Patients with severe disciform scarring
History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery within 60 days prior to screening
History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening
Inability to make study visits
Advanced glaucoma, uncontrolled glaucoma in the study eye (defined as intraocular pressure, IOP ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication)
Allergies to porphyrins or a known hypersensitivity to any component of Visudyne®