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Lucentis to Treat Pigment Epithelial Detachment

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Thomas G. Sheidow, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00841581
First received: February 9, 2009
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

Patients with Pigment Epithelial Detachments secondary to Age-Related Macular Degeneration (AMD) will receive intravitreal Lucentis monthly for 6 months in the hope of improving visual acuity from a baseline evaluation.


Condition Intervention Phase
Pigment Epithelial Detachment
Drug: Ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Lucentis (iL) (Ranibizumab) for the Treatment of AMD Related Pigment Epithelial Detachment (PED)

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • To investigate whether iL given monthly for 6 months in patients with Predominantly PED lesions (secondary to AMD) will significantly improve mean visual acuity from baseline on a standardized ETDRS chart. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on lesion growth and activity over the study period. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions alone on contrast sensitivity. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on lesion growth and activity over the study period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: December 2008
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lucentis
All patients receive iL for for first 6 months of study. At 6 months - patients are classified as "responders" or "non-responders". "Responders" receive iL PRN based on OCT,clinical exam etc. "Non-responders" are seen again at 12 months for repeat investigations.
Drug: Ranibizumab
Ranibizumab 0.5 mgs. (0.05 mls.) intravitreally for 6 months then as needed prn for 6 months.
Other Names:
  • Lucentis
  • DIN 02296810

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Predominantly PED type lesions as classified on IVFA and OCT secondary to AMD.
  2. PED under the geometric center of the foveal avascular zone.
  3. Evidence of recent disease progression as suggested by one or more of the following: sub-retinal lipid or cystic macular edema, sub-retinal hemorrhage, vision loss within the last 3 months or documented lesion growth on FA over previous 6 months.
  4. Visual acuity of between 20/40 and 20/800 in the study eye - Equivalent to Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 5 to 75 letters at 2 meters.
  5. Ambulatory Vision in the fellow eye
  6. Willingness and ability to participate and provide written informed consent.

Exclusion Criteria:

  1. Individuals with choroidal neovascularization from causes other than AMD.
  2. Patients physically unable to tolerate intravenous fluorescein angiography
  3. Any intraocular surgery within 2 months in the study eye.
  4. Prior retinal or vitreous surgery including vitrectomy or scleral buckling in the study eye.
  5. Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
  6. Individuals with physical or mental disabilities that prevent accurate vision testing.
  7. History of treatment of CNVM in the study eyes other than extrafoveal confluent laser photocoagulation.
  8. Prior photodynamic therapy for CNV.
  9. Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
  10. Women of childbearing potential who are not on two forms of effective contraception during the trial and for at least 60 days following the last dose of study medication.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841581

Locations
Canada, Ontario
Ivey Eye Institute
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Lawson Health Research Institute
Novartis Pharmaceuticals
Investigators
Principal Investigator: Thomas G Sheidow, MD Ivey Eye Institute, LOndon, Ontario, Canada
  More Information

No publications provided

Responsible Party: Thomas G. Sheidow, Vitreoretinal Surgeon, Associate professor of Ophthalmology, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00841581     History of Changes
Other Study ID Numbers: R-08-410, 15392
Study First Received: February 9, 2009
Last Updated: December 7, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Age Related Macular Degeneration
Pigment Epithelial Detachment
Intravitreal Detachment
Anti-VEGF

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Eye Diseases
Mental Disorders
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014