Immediate Effects of Lucentis® in Conjunction With Photodynamic Therapy With Visudyne® in Exudative AMD(IECOMB)
January 13, 2010 updated by: University Hospital Inselspital, Berne
Open-label, Phase II Study Assessing Immediate Effects of Lucentis®(Ranibizumab) Administered in Conjunction With Photodynamic Therapy With Visudyne® in Patients With Choroidal Neovascularization Secondary to AMD
This study is an evaluation of the short term effects on CNV perfusion of a same-day administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of Lucentis® (ranibizumab, 0.3 mg).
An evaluation of the short term effects on CNV perfusion of this combined treatment is needed for better understanding of treatment effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective is to quantify the short term effects on CNV perfusion of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab. These short term effects will be assessed with visual acuity measurements and ophthalmic examinations including indocyanine green (ICG) and fluorescein angiography (FA) as well as Optical Coherence Tomography (OCT) measurements. The primary variable for this assessment is the incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography. Fluorescein and ICG angiography will be performed using a scanning laser ophthalmoscope (HRA). All angiographic studies and OCT examinations will be evaluated by the Bern Photographic Reading Center in a masked fashion. Visual acuity assessments will be performed with Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts.
A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab:
- on retinal thickness as measured by OCT over time
- in change of total lesion area, area of CNV assessed by FA
- in mean change of VA from baseline over time
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bern, Switzerland
- Klinik und Poliklinik fuer Augenheilkunde, Inselspital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients 50 years of age or greater
- Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic, occult, or minimally classic.
- CNV lesion in the study eye is ≤5400 microns in greatest linear dimension
- Patients who have a best corrected visual acuity (BCVA) score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320) measured at 4 meters
- Willing to return for follow up scheduled visits for a 6 months period
- Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study
Exclusion Criteria:
- Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes
- Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy
- Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
- Focal laser photocoagulation (juxta-, extra- or subfoveal ) in the study eye
- Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). Note that ASA (aspirin) taken as "low dose" up to 100 mg daily (qd) for prophylaxis of myocardial infarction (MI) and/or stroke is permitted during study
- Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded
- History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (uveitis, cyclitis etc.)
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with topical anti-glaucomatous medication).
- Aphakia or absence of the posterior capsule in the study eye
- Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
- Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
- Presence of a retinal pigment epithelial tear involving the macula in the study eye
- Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
- Active intraocular inflammation (grade trace or above) in the study eye
- Any active infection involving an eyeball adnexa
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 1
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Intravitreal injection, photodynamic therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
retinal thickness as measured by OCT over time
Time Frame: 24 months
|
24 months
|
|
change of total lesion area, area of CNV and area of leakage over time as assessed by FA
Time Frame: 24 months
|
24 months
|
|
mean change of VA from baseline over time
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Sebastian Wolf, MD PhD, Klinik und Poliklinik fuer Augenheilkunde, Inselspital
- Principal Investigator: Ute Wolf-Schnurrbusch, MD, Klinik und Polklinik fuer Augenheilkunde, Inselspital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
December 19, 2006
First Submitted That Met QC Criteria
December 19, 2006
First Posted (Estimate)
December 20, 2006
Study Record Updates
Last Update Posted (Estimate)
January 14, 2010
Last Update Submitted That Met QC Criteria
January 13, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aug1202
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