Use of Spectral OCT in Combination Therapy

Choroidal Neovascularization Clinical Trial

— Spectral OCT  

Official title:

Use of Spectral OCT in Combination Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025063
• Other study ID #: CBPD952AUS18T
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: October 26, 2017
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2017
• Source: Barnes Retina Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Barnes Retina Institute	Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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