Use of Spectral OCT in Combination Therapy

Barnes Retina Institute0 sites15 target enrollmentJanuary 2008

ConditionsChoroidal Neovascularization

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Choroidal Neovascularization
Sponsor: Barnes Retina Institute
Enrollment: 15
Primary Endpoint: 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.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

December 2009

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Barnes Retina Institute

Responsible Party

Principal Investigator

Rhonda Weeks

Gaurav K. Shah, MD

Barnes Retina Institute

Eligibility Criteria

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:
•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

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

Outcomes

Primary Outcomes

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