NCT00590694

Brief Summary

Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

3.2 years

First QC Date

December 26, 2007

Last Update Submit

April 10, 2012

Conditions

Age-related Macular DegenerationPigment Epithelial DetachmentNeovascular Macular DegenerationWet Macular Degeneration

Keywords

ranibizumabLucentisPigment Epithelial DetachmentMacular DegenerationPrONTO

Outcome Measures

Primary Outcomes (1)

  • Mean change in visual acuity from baseline over 12 months

    12 months

Secondary Outcomes (3)

  • Time to OCT resolution of macular edema and pigment epithelial detachment

    One year

  • Proportion of patients with complete resolution of PED at 6 and 12 months

    12 months

  • Durability of outcome: time from last ranibizumab injection to retreatment

    One year

Study Arms (2)

Group1

ACTIVE COMPARATOR

Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.

Drug: ranibizumab

Group 2

ACTIVE COMPARATOR

Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.

Drug: ranibizumab

Interventions

ranibizumabDRUG

0.5mg injection monthly according to protocol for one year

Also known as: Lucentis injection
Group 2Group1

Eligibility Criteria

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

You may qualify if:

  • Neovascular age-related macular degeneration patients over age 50
  • Presence of a pigment epithelial detachment on optical coherence tomography
  • Initial or recurrent disease
  • Previous treatment allowed
  • Visual acuity between Snellen 20/40 - 20/400

You may not qualify if:

  • More than three previous treatments with PDT or other radiation/laser therapy
  • Previous vitrectomy or other AMD surgical intervention
  • Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)
  • Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Eye Associates

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83. doi: 10.1016/j.ajo.2007.01.028.

    PMID: 17386270BACKGROUND

Related Links

MeSH Terms

Conditions

Macular DegenerationRetinal DetachmentWet 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

  • Anne Fung, MD

    Pacific Eye Associates / California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

October 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations

US(1)