Lucentis KAV Study

NCT01570608 | Completed Phase 3

• 2 other identifiers: EK 06-233-01072006-006760-28
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Age Related Macular Degeneration

Keywords

Ranibizumab; Bevacizumab; Verteporfin; age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• number of injections

  Comparision of the number of required retreatments between the groups

  baseline-month 12

Secondary Outcomes (3)

• number of AE, SAE

  12 months

• central retinal thickness

  baseline-month 12

• distance acuity

  baseline-month 12

Study Arms (2)

monotherapy arm

ACTIVE COMPARATOR

patients receiving 3 initial Ranibizumab injections, thereafter as needed

Drug: Ranibizumab

combined treatment arm

ACTIVE COMPARATOR

Drug: Ranibizumab; Drug: Verteporfin

Interventions

Ranibizumab DRUG

intravitreal injection 3 monthly injections thereafter as needed

combined treatment arm; monotherapy arm

Verteporfin DRUG

Verteporfin photodynamic therapy standard fluence

combined treatment arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery: lead

Study Sites (3)

Department of OPhthalmology Medical center east

Vienna, Vienna, A1030, Austria

Location

Department of Ophthalmology Rudolf foundation Clinic

Vienna, Vienna, A1030, Austria

Location

Department of Ophthalmology, Hospital Hietzing

Vienna, Vienna, A1030, Austria

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab; Verteporfin

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Ilse Krebs, MD

  Ludwig Boltzmann Institute for retinology and biomicroscopic Lasersurgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2012
• First Posted: April 4, 2012
• Study Start: March 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 4, 2012

Record last verified: 2012-04

Locations

AU (3)