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OpenTrials
Completed

NCT Number: NCT01469156

Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Southeast Retina Center

Augusta, Georgia, 30909, United States

About this study

Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 1.0 or 2.0 mg/0.5mg (3:1 ratio) Ranibizumab injection with the first injection occuring at Day 0 and second and third injection occuring at month 1 and month 2 respectively. Retreatment with intravitreal Ranibizumab or other therapies will be at the investigators discretion but guidelines for recommended retreatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and Females >18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control.
  • ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid diagnosed within the past 6 months or diagnosed as newly active within the past 6 months. Subjects who completed the 24 month follow up in the original FVF3671s protocol may enter the study without necessarily demonstrating active exudative PCV at enrollment.
  • Best-Corrected ETDRS Visual Acuity at 4 meters between 20/20 - 20/800.
  • Lesion size - no limitations.
  • Lesions Characteristics - leaking lesions consistent with PCV. No limitations on hemorrhage, fibrosis or atrophy.
  • No therapy (includes non foveal laser, PDT, intravitreal steroids, TTT, radiotherapy, or anti-VEGF therapy) or intraocular surgery within the past 30 days for any condition.
  • Clear ocular media to allow for photography/angiography.
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion criteria

  • Patients with features of age related macular degeneration such as abundant drusen and demographic features consistent with this diagnosis.
  • Allergy to Fluorescein, ICG, Iodine, Shellfish.
  • Pregnancy (positive pregnancy test)
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  • Participation in another simultaneous medical investigation or trial.
  • Exclude other anti-VEGF agents as therapy options.
  • History of previous subfoveal laser.
  • Advanced glaucoma (IOP > 25 or cup/disc ration > 0.8)
  • Any condition in the opinion of the investigator that would interfere with disease status/progression or jeopardize patients' participation in the study.

Treatment and study plan

ranibizumab 0.5 or 2.0 mg/0.05 cc

Drug

ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.

Other names: Lucentis

Primary outcomes

  1. Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.

    Time frame: 2 years

    Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure - related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.

Secondary outcomes

  1. Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months

    Time frame: 12 months

  2. Change in Mean Central Foveal Thickness From Baseline

    Time frame: 12 Months

  3. Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months

    Time frame: 12 Months

  4. Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters

    Time frame: 3 Months

  5. Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters

    Time frame: 6 months

  6. Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters

    Time frame: 9 Months

  7. Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters

    Time frame: 12 Months

  8. Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12

    Time frame: 12 months

  9. Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters

    Time frame: 3 months

  10. Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters

    Time frame: 6 months

  11. Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters

    Time frame: 9 months

  12. Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Southeast Retina Center, Georgia

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Treatment of Polypoidal Choroidal Vasculopathy With High Dose Ranibizumab (Lucentis): A Phase I Safety Study.

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 10, 2011
Registry last updated
Dec 12, 2022

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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