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Use of Spectral OCT in Combination Therapy (Spectral OCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01025063
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Rhonda Weeks, Barnes Retina Institute

Study Description
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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.

Condition or disease
Choroidal Neovascularization

Study Design
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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Spectral OCT in Combination Therapy
Study Start Date : January 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Barnes Retina Institute clinic
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:

    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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Rhonda Weeks, Gaurav K. Shah, MD, Barnes Retina Institute
ClinicalTrials.gov Identifier: NCT01025063    
Other Study ID Numbers: CBPD952AUS18T
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Keywords provided by Rhonda Weeks, Barnes Retina Institute:
Spectral OCT
Choroidal Neovascularization
Lucentis
 Visudyne
PDT
anti-VEGF
Additional relevant MeSH terms:
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Choroidal Neovascularization
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
 Choroid Diseases
Uveal Diseases
Eye Diseases