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Lucentis KAV Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01570608
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : April 4, 2012
Information provided by (Responsible Party):
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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).

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: Ranibizumab Drug: Verteporfin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : March 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. number of injections [ Time Frame: baseline-month 12 ]
    Comparision of the number of required retreatments between the groups

Secondary Outcome Measures :
  1. number of AE, SAE [ Time Frame: 12 months ]
    number of AE and SAE

  2. central retinal thickness [ Time Frame: baseline-month 12 ]
    central retinal thickness measured by OCT

  3. distance acuity [ Time Frame: baseline-month 12 ]
    change of disance acuity measured by ETDRS letter scores

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01570608

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Department of OPhthalmology Medical center east
Vienna, Austria, A1030
Department of Ophthalmology Rudolf foundation Clinic
Vienna, Austria, A1030
Department of Ophthalmology, Hospital Hietzing
Vienna, Austria, A1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
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Study Director: Ilse Krebs, MD Ludwig Boltzmann Institute for retinology and biomicroscopic Lasersurgery
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Responsible Party: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery Identifier: NCT01570608    
Other Study ID Numbers: EK 06-233-0107
2006-006760-28 ( EudraCT Number )
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012
Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
age-related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents