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Completed

NCT Number: NCT00395707

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Retina Institute, Chevy Chase, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lucentis

Drug

0.3mg/0.05 ml or 0.5mg/0.05 ml

Other names: Ranibizumab

ranibizumab

Drug

0.3mg/0.05 ml or 0.5mg/0.05 ml

Other names: Lucentis

Ranibizumab (Lucentis)

Drug

0.3mg/0.05 ml intravitreally

Other names: Ranibizumab, Lucentis

Primary outcomes

  1. Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters

    Time frame: 2 years

  2. 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

  3. Incidence and severity of ocular adverse events

    Time frame: 12 months

  4. Incidence and severity of non-ocular adverse events

    Time frame: 12 months

  5. Changes in vital signs

    Time frame: 12 months

Secondary outcomes

  1. Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions

    Time frame: 12 months

  2. Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT

    Time frame: 2 years

  3. Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography

    Time frame: 2 years

  4. 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

  5. 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

  6. Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The National Retina Institute

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 3, 2006
Registry last updated
Feb 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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