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

NCT00701181 | Terminated Phase 2 DMC

• 1 other identifier: B0451004
• Study Type: interventional
• Target: 184
• Locations: 8 countries
• Sites: 53

Brief Summary

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

Conditions

Diabetic Retinopathy; Diabetes Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in the Best Corrected Visual Acuity Score

  Month 24

Secondary Outcomes (9)

• 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.

  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

Study Arms (4)

Laser

ACTIVE COMPARATOR

This is a procedure - not a drug intervention.

Procedure: Laser Treatment

PF-04523655 (High)

EXPERIMENTAL

Drug: PF-04523655 high

PF-04523655 middle

EXPERIMENTAL

Drug: PF-04523655 middle

PF-04523655 low

EXPERIMENTAL

Drug: PF-04523655 low

Interventions

Laser Treatment PROCEDURE

Necessity of laser treatment is assessed every three months.

Laser

PF-04523655 high DRUG

3 mg intravitreal injection

PF-04523655 (High)

PF-04523655 middle DRUG

1 mg intravitreal injection

PF-04523655 middle

PF-04523655 low DRUG

0.4 mg intravitreal injection

PF-04523655 low

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Quark Pharmaceuticals: lead
• Pfizer: collaborator

Study Sites (53)

Pfizer Investigational Site

Mesa, Arizona, 85210, United States

Location

Pfizer Investigational Site

Meza, Arizona, 85210, United States

Location

Pfizer Investigational Site

Peoria, Arizona, 85381, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85014, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85016, United States

Location

Pfizer Investigational Site

Mountain View, California, 94040, United States

Location

Pfizer Investigational Site

Lakeland, Florida, 33805, United States

Location

Pfizer Investigational Site

Winter Haven, Florida, 33880, United States

Location

Pfizer Investigational Site

Augusta, Georgia, 30909, United States

Location

Pfizer Investigational Site

‘Aiea, Hawaii, 96701, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60637, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46290, United States

Location

Pfizer Investigational Site

New Albany, Indiana, 47150, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21287, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02111, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Henderson, Nevada, 89052, United States

Location

Pfizer Investigational Site

Henderson, Nevada, 89074, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89109, United States

Location

Pfizer Investigational Site

Portsmouth, New Hampshire, 03801, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28210, United States

Location

Pfizer Investigational Site

High Point, North Carolina, 27262, United States

Location

Pfizer Investigational Site

Statesville, North Carolina, 28677, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27157, United States

Location

Pfizer Investigational Site

Rapid City, South Dakota, 57701, United States

Location

Pfizer Investigational Site

Corpus Christi, Texas, 78413, United States

Location

Pfizer Investigational Site

Glostrup Municipality, 2600, Denmark

Location

Pfizer Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

Pfizer Investigational Site

Leipzig, 04103, Germany

Location

Pfizer Investigational Site

Münster, 48145, Germany

Location

Pfizer Investigational Site

Bhubaneshwar, Odisha, 751 024, India

Location

Pfizer Investigational Site

Ahmedabad, 380 004, India

Location

Pfizer Investigational Site

Bangalore, 560 085, India

Location

Pfizer Investigational Site

New Delhi, 110 029, India

Location

Pfizer Investigational Site

Kfar Saba, 44281, Israel

Location

Pfizer Investigational Site

Petah Tikva, 49100, Israel

Location

Pfizer Investigational Site

Tel Aviv, 64239, Israel

Location

Pfizer Investigational Site

Tel Litwinsky, 52621, Israel

Location

Pfizer Investigational Site

Ẕerifin, 70300, Israel

Location

Pfizer Investigational Site

Milan, 20122, Italy

Location

Pfizer Investigational Site

Milan, 20132, Italy

Location

Pfizer Investigational Site

Milan, 20157, Italy

Location

Pfizer Investigational Site

Padua, 35128, Italy

Location

Pfizer Investigational Site

Roma, 00168, Italy

Location

Pfizer Investigational Site

Roma, 00198, Italy

Location

Pfizer Investigational Site

Udine, 33100, Italy

Location

Pfizer Investigational Site

Lima, Lima Province, L27, Peru

Location

Pfizer Investigational Site

Frimley, Camberley, Surrey, GU15 3UW, United Kingdom

Location

Pfizer Investigational Site

Bristol, BS1 2LX, United Kingdom

Location

Pfizer Investigational Site

Bristol, BS2 8HW, United Kingdom

Location

Pfizer Investigational Site

Liverpool, L7 8XP, United Kingdom

Location

Pfizer Investigational Site

Sheffield, S10 2JF, United Kingdom

Location

Pfizer Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23074206 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Complications

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

IT (7); DE (3); DK (1); PE (1); GB (6); US (26); IN (4); IL (5)