Immediate Effects of Lucentis® in Conjunction With Photodynamic Therapy With Visudyne® in Exudative AMD(IECOMB)

Insel Gruppe AG, University Hospital Bern

Status and phase

Completed

Phase 2

Conditions

Age Related Macular Degeneration

Treatments

Drug: Intravitreal ranibizumab with photodynamic therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00413829

Aug1202

Details and patient eligibility

About

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.

Full 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

Enrollment

20 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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