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

  Hide Detailed Description

Detailed Description:

Background:

Exudative Age Related Macular Degeneration (AMD) results in a significant and severe visual loss if left untreated as documented in natural history and observational arms of studies such as the macular photocoagulation study (MPS) and the Tap and VIP study with Visudyne. It is also clear however, that the different lesion types (classified by intravenous fluorescein angiography ((IVFA)) as occult, minimally classic or predominately classic) have both a different natural history and a different response to treatment.

The recent introduction of the anti-VEGF agents such as Macugen and Lucentis have significantly advanced our ability to treat AMD as both agents show clear efficacy across all lesion subtypes regardless of lesion composition.

A clear absence of literature on clinical outcomes exist however for fibrovascular pigment epithelial detachments (PED). PED represents a form of exudative AMD which clearly behaves in a unique and distinctive manner when compared to the lesion(s) described above.

As standard exclusion criteria within most of the major AMD trials, lesion composition of any IVFA subtype is acceptable as long as less then 50% of the lesion is composed of blood or pigment epithelial detachment. This has resulted in a notable absence of clinical literature on the response of predominately PED type lesions to current standard of care anti-VEGF agents. In an effort to address this absence, a prospective evaluation of the response of predominately PED type lesions to Lucentis, the current gold standard therapy is needed.

Study design:

Thirty two patients will be recruited to participate based on the Inclusion / Exclusion Criteria described in a later paragraph.

Patients will receive monthly intravitreal Lucentis injections every 33 days (+/- 4 days) for 6 months. At 6 months, patients will be evaluated based on ETDRS Visual Acuity and OCT to determine response to Lucentis therapy. Patients not experiencing a visual improvement from baseline ETDRS acuity (defined as a net gain from baseline of 10 or more letters) or showing a reduction in the height of the fibrovascular PED lesion on OCT of greater than 30% from baseline OCT will be deemed Lucentis non-responders. These patients will receive no further intravitreal Lucentis injections, but will undergo re-evaluation at 12 months.

Patients deemed responders, will continue with an OCT-guided 6 months active treatment period. In these patients, iL will be administered if evidence of visual loss of 1 or more lines (Snellen) from 6-month visit values, evidence of intraretinal or subretinal fluid on OCT, or growth of PED by greater than 50 microns from the 6-month visit OCT values.

Non-responders will be evaluated only at the 12-month final visit.

Baseline IVFA, OCT, Snellen Visual Acuity, ETDRS refraction and contrast sensitivity will be obtained along with a comprehensive ophthalmological examination. Complete diagnostic assessments including fluorescein angiography, OCT and visual function testing will be repeated at 3, 6 and 12 months after baseline treatment. In addition, patients who will continue on active intravitreal Lucentis therapy beyond 6 months (responders), will undergo monthly OCT examinations (months 6 through 11) and ophthalmic safety examinations in order to determine the need for Lucentis administration.

At the final, Month 12 visit, all patients will undergo ophthalmic examination, OCT, ETDRS refraction, Snellen Visual Acuity and contrast sensitivity.

  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 October 23, 2014