NCT00457470

Brief Summary

This study will evaluate the safety and efficacy of AG-014699 in diabetic patients

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

First Submitted

Initial submission to the registry

April 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

First QC Date

April 4, 2007

Last Update Submit

April 30, 2015

Conditions

Diabetes MellitusDiabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen

Secondary Outcomes (4)

  • Proportion of subjects with reduction in retinal thickness from baseline in 2 months

  • Change in retinal thickness for 2 months

  • Change in visual acuity for 2 months

  • ; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28

Interventions

AG-014699DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age

You may not qualify if:

  • patients treated with laser therapy within the last 90 days
  • patients with likelyhood to require cataract surgery within 3 months
  • Uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Interventions

rucaparib

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 6, 2007

Study Start

June 1, 2007

Last Updated

May 4, 2015

Record last verified: 2015-04