A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)

A Phase 2, Multi-Stage, Multi-Center Trial Exploring The Safety And Efficacy Of AG-014699 In Subjects With Diffuse Diabetic Macular Edema (DME) Involving The Center Of The Retina

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00457470

Enrollment

Registered

2007-04-06

Start date

2007-06-30

Completion date

Unknown

Last updated

2015-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetic Retinopathy

Brief summary

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

Interventions

DRUGAG-014699

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen	—

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026