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See termination reason in detailed description.
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser | Active Comparator | This is a procedure - not a drug intervention. |
|
| PF-04523655 (High) | Experimental |
| |
| PF-04523655 middle | Experimental |
| |
| PF-04523655 low | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Treatment | Procedure | Necessity of laser treatment is assessed every three months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in the Best Corrected Visual Acuity Score | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Changes in NEI-VFQ-25 Composite Score from Baseline | Month 24, 36 | |
| Plasma Concentration of PF-04523655 | Week 1 | |
| Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Mesa | Arizona | 85210 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23074206 | Derived | Nguyen QD, Schachar RA, Nduaka CI, Sperling M, Basile AS, Klamerus KJ, Chi-Burris K, Yan E, Paggiarino DA, Rosenblatt I, Aitchison R, Erlich SS; DEGAS Clinical Study Group. Dose-ranging evaluation of intravitreal siRNA PF-04523655 for diabetic macular edema (the DEGAS study). Invest Ophthalmol Vis Sci. 2012 Nov 15;53(12):7666-74. doi: 10.1167/iovs.12-9961. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PF-04523655 high |
| Drug |
3 mg intravitreal injection |
|
| PF-04523655 middle | Drug | 1 mg intravitreal injection |
|
| PF-04523655 low | Drug | 0.4 mg intravitreal injection |
|
| 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 Area of Fluorescein Leakage 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 |
| Meza |
| Arizona |
| 85210 |
| United States |
| Pfizer Investigational Site | Peoria | Arizona | 85381 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85014 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85016 | United States |
| Pfizer Investigational Site | Mountain View | California | 94040 | United States |
| Pfizer Investigational Site | Lakeland | Florida | 33805 | United States |
| Pfizer Investigational Site | Winter Haven | Florida | 33880 | United States |
| Pfizer Investigational Site | Augusta | Georgia | 30909 | United States |
| Pfizer Investigational Site | ‘Aiea | Hawaii | 96701 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60637 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46290 | United States |
| Pfizer Investigational Site | New Albany | Indiana | 47150 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21287 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02111 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | United States |
| Pfizer Investigational Site | Henderson | Nevada | 89052 | United States |
| Pfizer Investigational Site | Henderson | Nevada | 89074 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89109 | United States |
| Pfizer Investigational Site | Portsmouth | New Hampshire | 03801 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28210 | United States |
| Pfizer Investigational Site | High Point | North Carolina | 27262 | United States |
| Pfizer Investigational Site | Statesville | North Carolina | 28677 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| Pfizer Investigational Site | Rapid City | South Dakota | 57701 | United States |
| Pfizer Investigational Site | Corpus Christi | Texas | 78413 | United States |
| Pfizer Investigational Site | Glostrup Municipality | 2600 | Denmark |
| Pfizer Investigational Site | Freiburg im Breisgau | 79106 | Germany |
| Pfizer Investigational Site | Leipzig | 04103 | Germany |
| Pfizer Investigational Site | Münster | 48145 | Germany |
| Pfizer Investigational Site | Bhubaneswar | Odisha | 751 024 | India |
| Pfizer Investigational Site | Ahmedabad | 380 004 | India |
| Pfizer Investigational Site | Bangalore | 560 085 | India |
| Pfizer Investigational Site | New Delhi | 110 029 | India |
| Pfizer Investigational Site | Kfar Saba | 44281 | Israel |
| Pfizer Investigational Site | Petah Tikva | 49100 | Israel |
| Pfizer Investigational Site | Tel Aviv | 64239 | Israel |
| Pfizer Investigational Site | Tel Litwinsky | 52621 | Israel |
| Pfizer Investigational Site | Ẕerifin | 70300 | Israel |
| Pfizer Investigational Site | Milan | 20122 | Italy |
| Pfizer Investigational Site | Milan | 20132 | Italy |
| Pfizer Investigational Site | Milan | 20157 | Italy |
| Pfizer Investigational Site | Padova | 35128 | Italy |
| Pfizer Investigational Site | Roma | 00168 | Italy |
| Pfizer Investigational Site | Roma | 00198 | Italy |
| Pfizer Investigational Site | Udine | 33100 | Italy |
| Pfizer Investigational Site | Lima | Lima Province | L27 | Peru |
| Pfizer Investigational Site | Frimley | Camberley, Surrey | GU15 3UW | United Kingdom |
| Pfizer Investigational Site | Bristol | BS1 2LX | United Kingdom |
| Pfizer Investigational Site | Bristol | BS2 8HW | United Kingdom |
| Pfizer Investigational Site | Liverpool | L7 8XP | United Kingdom |
| Pfizer Investigational Site | Sheffield | S10 2JF | United Kingdom |
| Pfizer Investigational Site | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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