Lucentis KAV Study

Comparison of Ranibizumab (Lucentis) Monotherapy Versus Combination of Ranibizumab (Lucentis) With Photodynamic Therapy (Verteporfin) in Patients With Subfoveal Choroidal Neovascularisation Due to Age-Related Macular Degeneration - a Pilot Study

Ranibizumab has been proven to be effective in large multicentre studies. However, the injections have to be repeated monthly. A combined therapy with the established photodynamic therapy might even be more effective, less intravitreal injections might be necessary due to a synergistic effect.

The study will be conducted to explore whether intravitreal ranibizumab in monotherapy or in combination with verteporfin photodynamic therapy under a new time regime is an effective, safe and convenient treatment for patients with subfoveal Choroidal Neovascularisation (CNV) secondary to Age-Related Macular Degeneration (AMD).

Study Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration
• Intervention / Treatment: Drug: Ranibizumab; Drug: Verteporfin

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A1030
    • Department of OPhthalmology Medical center east
  • Vienna, Austria, A1030
    • Department of Ophthalmology Rudolf foundation Clinic
  • Vienna, Austria, A1030
    • Department of Ophthalmology, Hospital Hietzing

Participation Criteria

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:

• BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart measured at 4 meters or Snellen equivalent

• CNV lesion of any type in the study eye which meets all the following characteristics as determined by fluorescein angiography:

  • Evidence that CNV extends under the geometric center of the foveal avascular zone.
  • The area of the CNV must occupy at least 50% of the total lesion.
  • The lesion must be ≤ 5400 microns in greatest linear dimension (GLD)

• For occult with no classic CNV, additionally recent disease progression as assessed by the Investigator is required defined as having at least one of the following criteria:

  • Blood associated with the lesion at baseline
  • Loss of VA in the previous 3 months defined as either ≥ 5 letters (ETDRS equivalent) as determined by protocol refraction and protocol measurements, or 2 or more lines using a Snellen or equivalent chart by standard examinations. ≥ 10% increase in the greatest diameter of the lesion in the previous 3 months as assessed by fluorescein angiography
• Willing to return for scheduled visits for a 12 month 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 qd for prophylaxis of MI and/or stroke is permitted during study
• Current use or of 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 mediation).
• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: monotherapy arm; patients receiving 3 initial Ranibizumab injections, thereafter as needed	Drug: Ranibizumab; intravitreal injection 3 monthly injections thereafter as needed
Active Comparator: combined treatment arm	Drug: Ranibizumab; intravitreal injection 3 monthly injections thereafter as needed; Drug: Verteporfin; Verteporfin photodynamic therapy standard fluence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of injections	Comparision of the number of required retreatments between the groups	baseline-month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of AE, SAE	number of AE and SAE	12 months
central retinal thickness	central retinal thickness measured by OCT	baseline-month 12
distance acuity	change of disance acuity measured by ETDRS letter scores	baseline-month 12

Collaborators and Investigators

• Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Investigators: Study Director: Ilse Krebs, MD, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: April 1, 2012
• First Submitted That Met QC Criteria: April 3, 2012
• First Posted (Estimate): April 4, 2012

Study Record Updates

• Last Update Posted (Estimate): April 4, 2012
• Last Update Submitted That Met QC Criteria: April 3, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Bevacizumab; Ranibizumab; Verteporfin; age-related macular degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Photosensitizing Agents; Dermatologic Agents; Ranibizumab; Verteporfin
• Other Study ID Numbers: EK 06-233-0107; 2006-006760-28 (EudraCT Number)