Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema

A Phase II Prospective, Randomized, Multi-Center, Diabetic Macular Edema Dose Ranging, Comparator Study Evaluating The Efficacy And Safety Of PF-04523655 Versus Laser Therapy (DEGAS)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00701181

Acronym

DEGAS

Enrollment

184

Registered

2008-06-19

Start date

2008-06-30

Completion date

2011-01-31

Last updated

2012-10-11

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

Conditions

Diabetes Complications, Diabetic Retinopathy

Keywords

Phase II, Prospective, Randomized, Diabetic Macular Edema, PF-04523655, Laser

Brief summary

To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema

Detailed description

DEGAS termination decision date was December 17, 2010. Rationale: the objectives of the study could no longer be achieved. The study was not terminated for safety.

Interventions

PROCEDURELaser Treatment

Necessity of laser treatment is assessed every three months.

DRUGPF-04523655 high

3 mg intravitreal injection

DRUGPF-04523655 middle

1 mg intravitreal injection

DRUGPF-04523655 low

0.4 mg intravitreal injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye.

Exclusion criteria

* Proliferative Diabetic Retinopathy in the Study Eye. * Subjects Receiving Concomitant Intravitreal Anti-VEGF Therapy.

Design outcomes

Primary

Measure	Time frame
Mean Change from Baseline in the Best Corrected Visual Acuity Score	Month 24

Secondary

Measure	Time frame
Plasma Concentration of PF-04523655	Week 1
Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline.	Month 24, 36
Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination	Month 24, 36
Mean Change from Baseline in the Best Corrected Visual Acuity Score	Month 36
Mean Changes in NEI-VFQ-25 Composite Score from Baseline	Month 24, 36
Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline.	Month 24, 36
Mean Changes in Retinal Thickness from Baseline	Month 24, 36
Mean Changes in Macular Volume from Baseline	Month 24, 36
Mean Changes in Area of Fluorescein Leakage from Baseline	Month 24, 36

Countries

Denmark, Germany, India, Israel, Italy, Peru, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026