NCT00395707

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

2.7 years

First QC Date

November 1, 2006

Last Update Submit

February 6, 2009

Conditions

Macular Degeneration

Keywords

Macular DegenerationAge Related Macular DegenerationRetinal Angiomatous Proliferations

Outcome Measures

Primary Outcomes (5)

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

    2 years

  • Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline

    12 months

  • Incidence and severity of ocular adverse events

    12 months

  • Incidence and severity of non-ocular adverse events

    12 months

  • Changes in vital signs

    12 months

Secondary Outcomes (6)

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

    12 months

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

    2 years

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

    2 years

  • 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

    2 years

  • 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

    2 years

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Lucentis 0.3mg/0.05 ml

Drug: LucentisDrug: RanibizumabDrug: Ranibizumab (Lucentis)

2

ACTIVE COMPARATOR

Lucentis 0.5mg/0.05 ml

Drug: LucentisDrug: RanibizumabDrug: Ranibizumab (Lucentis)

Interventions

LucentisDRUG

0.3mg/0.05 ml or 0.5mg/0.05 ml

Also known as: Ranibizumab
12
RanibizumabDRUG

0.3mg/0.05 ml or 0.5mg/0.05 ml

Also known as: Lucentis
12
Ranibizumab (Lucentis)DRUG

0.3mg/0.05 ml intravitreally

Also known as: Ranibizumab, Lucentis
1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Retina Institute

Chevy Chase, Maryland, 20815, United States

Location

National Retina Institute

Towson, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Thomas M Johnson, MD

    National Retina Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 3, 2006

Study Start

August 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

US(2)