Use of Spectral OCT in Combination Therapy

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT01025063
First received: December 2, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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
Choroidal Neovascularization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Spectral OCT in Combination Therapy

Resource links provided by NLM:


Further study details as provided by Barnes Retina Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lucentis (PRN group)
Lucentis (3 Injections over three months)
PDT (Reduced Fluence) and Lucentis

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Gaurav Shah, MD, Barnes Retina Institute
ClinicalTrials.gov Identifier: NCT01025063     History of Changes
Other Study ID Numbers: CBPD952AUS18T
Study First Received: December 2, 2009
Last Updated: December 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Barnes Retina Institute:
Spectral OCT
Choroidal Neovascularization
Lucentis
Visudyne
PDT
anti-VEGF

Additional relevant MeSH terms:
Choroidal Neovascularization
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Uveal Diseases

ClinicalTrials.gov processed this record on October 23, 2014