Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
The National Retina Institute
ClinicalTrials.gov Identifier:
NCT00395707
First received: November 1, 2006
Last updated: February 6, 2009
Last verified: February 2009
  Purpose

The primary objective of this study is to determine the safety & efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.


Condition Intervention Phase
Macular Degeneration
Drug: Lucentis
Drug: Ranibizumab
Drug: Ranibizumab (Lucentis)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations

Resource links provided by NLM:


Further study details as provided by The National Retina Institute:

Primary Outcome Measures:
  • Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence and severity of ocular adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence and severity of non-ocular adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Changes in vital signs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Lucentis 0.3mg/0.05 ml
Drug: Lucentis
0.3mg/0.05 ml or 0.5mg/0.05 ml
Other Name: Ranibizumab
Drug: Ranibizumab
0.3mg/0.05 ml or 0.5mg/0.05 ml
Other Name: Lucentis
Drug: Ranibizumab (Lucentis)
0.3mg/0.05 ml intravitreally
Other Names:
  • Ranibizumab
  • Lucentis
Active Comparator: 2
Lucentis 0.5mg/0.05 ml
Drug: Lucentis
0.3mg/0.05 ml or 0.5mg/0.05 ml
Other Name: Ranibizumab
Drug: Ranibizumab
0.3mg/0.05 ml or 0.5mg/0.05 ml
Other Name: Lucentis
Drug: Ranibizumab (Lucentis)
0.5mg/0.05 ml
Other Names:
  • Ranibizumab
  • Lucentis

Detailed Description:

This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age > 50 years
  • Definite characteristic signs of age related macular degeneration including drusen
  • Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)

Exclusion Criteria:

  • Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)
  • Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
  • Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
  • Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
  • History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
  • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
  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: NCT00395707

Locations
United States, Maryland
National Retina Institute
Chevy Chase, Maryland, United States, 20815
National Retina Institute
Towson, Maryland, United States, 21204
Sponsors and Collaborators
The National Retina Institute
Genentech
Investigators
Principal Investigator: Thomas M Johnson, MD National Retina Institute
  More Information

No publications provided

Responsible Party: T. Mark Johnson, MD, National Retina Institute
ClinicalTrials.gov Identifier: NCT00395707     History of Changes
Other Study ID Numbers: FVF3423s
Study First Received: November 1, 2006
Last Updated: February 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by The National Retina Institute:
Macular Degeneration
Age Related Macular Degeneration
Retinal Angiomatous Proliferations

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014