Use of Spectral OCT in Combination Therapy (Spectral OCT)

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.

Study Overview

• Status: Completed
• Conditions: Choroidal Neovascularization

• Study Type: Observational
• Enrollment (Actual): 15

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Barnes Retina Institute clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Lucentis (PRN group)
Lucentis (3 Injections over three months)
PDT (Reduced Fluence) and Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Barnes Retina Institute
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 3, 2009

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: anti-VEGF; Lucentis; Visudyne; PDT; Choroidal Neovascularization; Spectral OCT
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic
• Other Study ID Numbers: CBPD952AUS18T