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Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema (DEGAS)
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Quark Pharmaceuticals
Collaborator:
Pfizer
Information provided by (Responsible Party):
Quark Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00701181
First received: June 17, 2008
Last updated: October 9, 2012
Last verified: October 2012
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Purpose
To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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) |
Resource links provided by NLM:
Further study details as provided by Quark Pharmaceuticals:
Primary Outcome Measures:
- Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 24 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 184 |
| Study Start Date: | June 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701181
Show 53 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701181
Show 53 Study Locations
Sponsors and Collaborators
Quark Pharmaceuticals
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
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 |
| Study First Received: | June 17, 2008 |
| Last Updated: | October 9, 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 |
ClinicalTrials.gov processed this record on August 16, 2017