Lucentis KAV Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT01570608
First received: April 1, 2012
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Age Related Macular Degeneration
Drug: Ranibizumab
Drug: Verteporfin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • number of injections [ Time Frame: baseline-month 12 ] [ Designated as safety issue: No ]
    Comparision of the number of required retreatments between the groups


Secondary Outcome Measures:
  • number of AE, SAE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    number of AE and SAE

  • central retinal thickness [ Time Frame: baseline-month 12 ] [ Designated as safety issue: No ]
    central retinal thickness measured by OCT

  • distance acuity [ Time Frame: baseline-month 12 ] [ Designated as safety issue: No ]
    change of disance acuity measured by ETDRS letter scores


Enrollment: 51
Study Start Date: March 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570608

Locations
Austria
Department of Ophthalmology Rudolf foundation Clinic
Vienna, Austria, A1030
Department of Ophthalmology, Hospital Hietzing
Vienna, Austria, A1030
Department of OPhthalmology Medical center east
Vienna, Austria, A1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Study Director: Ilse Krebs, MD Ludwig Boltzmann Institute for retinology and biomicroscopic Lasersurgery
  More Information

No publications provided

Responsible Party: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT01570608     History of Changes
Other Study ID Numbers: EK 06-233-0107, 2006-006760-28
Study First Received: April 1, 2012
Last Updated: April 3, 2012
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
Ranibizumab
Bevacizumab
Verteporfin
age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014