Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema (DEGAS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00701181 |
Recruitment Status
:
Terminated
(See termination reason in detailed description.)
First Posted
: June 19, 2008
Last Update Posted
: October 11, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Retinopathy Diabetes Complications | Procedure: Laser Treatment Drug: PF-04523655 high Drug: PF-04523655 middle Drug: PF-04523655 low | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 184 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Laser
This is a procedure - not a drug intervention.
|
Procedure: Laser Treatment
Necessity of laser treatment is assessed every three months.
|
Experimental: PF-04523655 (High) |
Drug: PF-04523655 high
3 mg intravitreal injection
|
Experimental: PF-04523655 middle |
Drug: PF-04523655 middle
1 mg intravitreal injection
|
Experimental: PF-04523655 low |
Drug: PF-04523655 low
0.4 mg intravitreal injection
|
- Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 24 ]
- Mean Changes in NEI-VFQ-25 Composite Score from Baseline [ Time Frame: Month 24, 36 ]
- Plasma Concentration of PF-04523655 [ Time Frame: Week 1 ]
- Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ]
- Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination [ Time Frame: Month 24, 36 ]
- Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 36 ]
- Mean Changes in Area of Fluorescein Leakage from Baseline [ Time Frame: Month 24, 36 ]
- Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ]
- Mean Changes in Retinal Thickness from Baseline [ Time Frame: Month 24, 36 ]
- Mean Changes in Macular Volume from Baseline [ Time Frame: Month 24, 36 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701181

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Quark Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00701181 History of Changes |
Other Study ID Numbers: |
B0451004 |
First Posted: | June 19, 2008 Key Record Dates |
Last Update Posted: | October 11, 2012 |
Last Verified: | October 2012 |
Keywords provided by Quark Pharmaceuticals:
Phase II Prospective Randomized |
Diabetic Macular Edema PF-04523655 Laser |
Additional relevant MeSH terms:
Macular Edema Diabetic Retinopathy Diabetes Complications Macular Degeneration Retinal Degeneration Retinal Diseases |
Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases |