Lucentis to Treat Pigment Epithelial Detachment

NCT00841581 | Completed Phase 2

• 2 other identifiers: R-08-41015392
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pigment Epithelial Detachment

Keywords

Age Related Macular Degeneration; Pigment Epithelial Detachment; Intravitreal Detachment; Anti-VEGF

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• 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.

  6 months

• To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions alone on contrast sensitivity.

  6 months

• 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).

  6 months

• 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.

  12 months

• 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).

  12 months

Study Arms (1)

Lucentis

EXPERIMENTAL

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

Interventions

Ranibizumab DRUG

Ranibizumab 0.5 mgs. (0.05 mls.) intravitreally for 6 months then as needed prn for 6 months.

Also known as: Lucentis, DIN 02296810

Lucentis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Predominantly PED type lesions as classified on IVFA and OCT secondary to AMD.
• PED under the geometric center of the foveal avascular zone.
• 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.
• 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.
• Ambulatory Vision in the fellow eye
• Willingness and ability to participate and provide written informed consent.

You may not qualify if:

• Individuals with choroidal neovascularization from causes other than AMD.
• Patients physically unable to tolerate intravenous fluorescein angiography
• Any intraocular surgery within 2 months in the study eye.
• Prior retinal or vitreous surgery including vitrectomy or scleral buckling in the study eye.
• Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
• Individuals with physical or mental disabilities that prevent accurate vision testing.
• History of treatment of CNVM in the study eyes other than extrafoveal confluent laser photocoagulation.
• Prior photodynamic therapy for CNV.
• Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Ivey Eye Institute

London, Ontario, N6A 4G5, Canada

Location

MeSH Terms

Conditions

Retinal Detachment; Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas G Sheidow, MD

  Ivey Eye Institute, LOndon, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vitreoretinal Surgeon, Associate professor of Ophthalmology

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 11, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

CA (1)