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

NCT ID: NCT00701181

Last Updated: 2012-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Retinopathy Diabetes Complications

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Phase II Prospective Randomized Diabetic Macular Edema PF-04523655 Laser

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laser

This is a procedure - not a drug intervention.

Group Type ACTIVE_COMPARATOR

Laser Treatment

Intervention Type PROCEDURE

Necessity of laser treatment is assessed every three months.

PF-04523655 (High)

Group Type EXPERIMENTAL

PF-04523655 high

Intervention Type DRUG

3 mg intravitreal injection

PF-04523655 middle

Group Type EXPERIMENTAL

PF-04523655 middle

Intervention Type DRUG

1 mg intravitreal injection

PF-04523655 low

Group Type EXPERIMENTAL

PF-04523655 low

Intervention Type DRUG

0.4 mg intravitreal injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laser Treatment

Necessity of laser treatment is assessed every three months.

Intervention Type PROCEDURE

PF-04523655 high

3 mg intravitreal injection

Intervention Type DRUG

PF-04523655 middle

1 mg intravitreal injection

Intervention Type DRUG

PF-04523655 low

0.4 mg intravitreal injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

Quark Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Mesa, Arizona, United States

Site Status

Pfizer Investigational Site

Meza, Arizona, United States

Site Status

Pfizer Investigational Site

Peoria, Arizona, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Mountain View, California, United States

Site Status

Pfizer Investigational Site

Lakeland, Florida, United States

Site Status

Pfizer Investigational Site

Winter Haven, Florida, United States

Site Status

Pfizer Investigational Site

Augusta, Georgia, United States

Site Status

Pfizer Investigational Site

‘Aiea, Hawaii, United States

Site Status

Pfizer Investigational Site

Chicago, Illinois, United States

Site Status

Pfizer Investigational Site

Indianapolis, Indiana, United States

Site Status

Pfizer Investigational Site

New Albany, Indiana, United States

Site Status

Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Henderson, Nevada, United States

Site Status

Pfizer Investigational Site

Henderson, Nevada, United States

Site Status

Pfizer Investigational Site

Las Vegas, Nevada, United States

Site Status

Pfizer Investigational Site

Portsmouth, New Hampshire, United States

Site Status

Pfizer Investigational Site

Charlotte, North Carolina, United States

Site Status

Pfizer Investigational Site

High Point, North Carolina, United States

Site Status

Pfizer Investigational Site

Statesville, North Carolina, United States

Site Status

Pfizer Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Pfizer Investigational Site

Rapid City, South Dakota, United States

Site Status

Pfizer Investigational Site

Corpus Christi, Texas, United States

Site Status

Pfizer Investigational Site

Glostrup Municipality, , Denmark

Site Status

Pfizer Investigational Site

Freiburg im Breisgau, , Germany

Site Status

Pfizer Investigational Site

Leipzig, , Germany

Site Status

Pfizer Investigational Site

Münster, , Germany

Site Status

Pfizer Investigational Site

Bhubaneshwar, Odisha, India

Site Status

Pfizer Investigational Site

Ahmedabad, , India

Site Status

Pfizer Investigational Site

Bangalore, , India

Site Status

Pfizer Investigational Site

New Delhi, , India

Site Status

Pfizer Investigational Site

Kfar Saba, , Israel

Site Status

Pfizer Investigational Site

Petah Tikva, , Israel

Site Status

Pfizer Investigational Site

Tel Aviv, , Israel

Site Status

Pfizer Investigational Site

Tel Litwinsky, , Israel

Site Status

Pfizer Investigational Site

Ẕerifin, , Israel

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Padua, , Italy

Site Status

Pfizer Investigational Site

Roma, , Italy

Site Status

Pfizer Investigational Site

Roma, , Italy

Site Status

Pfizer Investigational Site

Udine, , Italy

Site Status

Pfizer Investigational Site

Lima, Lima Province, Peru

Site Status

Pfizer Investigational Site

Frimley, Camberley, Surrey, United Kingdom

Site Status

Pfizer Investigational Site

Bristol, , United Kingdom

Site Status

Pfizer Investigational Site

Bristol, , United Kingdom

Site Status

Pfizer Investigational Site

Liverpool, , United Kingdom

Site Status

Pfizer Investigational Site

Sheffield, , United Kingdom

Site Status

Pfizer Investigational Site

Southampton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil United States Denmark Germany India Israel Italy Peru United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23074206 (View on PubMed)

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B0451004

Identifier Type: -

Identifier Source: org_study_id