Use of Spectral OCT in Combination Therapy

Barnes Retina Institute

Status: Completed

Conditions: Choroidal Neovascularization

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01025063

CBPD952AUS18T

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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:

  1. Blood associated with the lesion at baseline
  2. 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
  3. > 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months

Exclusion criteria

• 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®
• Patients with porphyria
• Pregnancy or lactation

Trial design

15 participants in 3 patient groups

Lucentis (PRN group)

Lucentis (3 Injections over three months)

PDT (Reduced Fluence) and Lucentis