Combination of Ranibizumab and Verteporfin Therapy in Neovascular Age-related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by:
Novartis Korea Ltd.
ClinicalTrials.gov Identifier:
NCT00967213
First received: August 26, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

The purpose of this study is to evaluate changes in preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF) in patients with neovascular age-related macular degeneration receiving combination of ranibizumab (LucentisTM) and verteporfin (Visudyne®) therapy


Condition Intervention Phase
Neovascular Age-related Macular Degeneration
Drug: ranibizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Changes in Preferential Hyperacuity Perimeter (PHP) and Fundus Autofluorescence (FAF) in Patients With Neovascular Age-related Macular Degeneration Receiving Combination of Ranibizumab and Verteporfin Therapy

Resource links provided by NLM:


Further study details as provided by Novartis Korea Ltd.:

Primary Outcome Measures:
  • The change in ETDRS visual acuity letter scores from baseline. [ Time Frame: every 4 weeks (up to 52 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect on CNV and RPE using preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF). Retinal thickness using optical coherence tomography (OCT). Recurrence of fluorescein leakage. The need for additional PDT treatment [ Time Frame: every 4 weeks (up to 52 weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: August 2006
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab
three session of monthly injection of Lucentis® (week 0, 4, 8). After 4 weeks from third injection, a session of verteporfin PDT (week 12) and fourth injection of Lucentis® (week 16) will be added at intervals of 4 weeks. Two more combined treatment with verteporfin PDT and Lucentis® injection 4 weeks apart can be added at the treating physician's discretion in 3-month intervals (week 28, week 40).
Drug: ranibizumab
Lucentis® (ranibizumab) 0.3mg (0.05ml volume) intravitreal injection. Eligible patients will be initially received three session of monthly injection of Lucentis® (week 0, 4, 8). After 4 weeks from third injection, a session of verteporfin PDT (week 12) and fourth injection of Lucentis® (week 16) will be added at intervals of 4 weeks. Two more combined treatment with verteporfin PDT and Lucentis® injection 4 weeks apart can be added at the treating physician's discretion in 3-month intervals (week 28, week 40).
Other Name: Lucentis

  Eligibility

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

Inclusion Criteria:

  • Signed written informed consent
  • Age ≥ 50 years old
  • Patients with primary active subfoveal CNV secondary to AMD
  • Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/40 to 20/400 using ETDRS chart
  • Characteristics of AMD lesion

    • predominantly or minimally classic, or occult
    • absence of prior subfoveal treatment for macular disease
    • total lesion size ≤ 9 optic disc areas, with CNV component ≥ 50% of the lesion (unless a serous pigment epithelial detachment was present, in which case < 50% CNV was acceptable)
    • active choroidal neovascularization leakage
    • submacular blood < 50% and subretinal fibrosis < 25% of the total lesion

Exclusion Criteria:

  • additional eye disease that could compromise VA
  • CNV unrelated to AMD
  • ocular inflammation
  • vitreous hemorrhage
  • retinal hemorrhage (other than AMD related submacular blood) > 1 disc areas
  • intraocular surgery ≤ 1 month before day 0
  • uncontrolled glaucoma
  • prior treatments with verteporfin PDT
  • laser photocoagulation or other intervention for AMD
  • previous treatment with external-beam radiation therapy or transpupillary thermotherapy
  • history of vitrectomy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967213

Locations
Korea, Republic of
Dept. of Ophthalmology, KyungHee Medical Center, #1 Hoegi, Dongdaemun-gu
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Novartis Korea Ltd.
Investigators
Principal Investigator: Hyung-Woo Kwak Dept. of ophthalmology, KyungHee Medical Center
  More Information

No publications provided

Responsible Party: Hyung-Woo Kwak / professor, Department of ophthalmology, Kyunghee Medical Center
ClinicalTrials.gov Identifier: NCT00967213     History of Changes
Other Study ID Numbers: CBPD952AKR03, CCT-NAPN-18335
Study First Received: August 26, 2009
Last Updated: August 26, 2009
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 27, 2014