A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema

Pfizer243 enrolled

Overview

The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.

During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

243

Conditions

Macular Edema Diabetic Mellitus Retinal Disease

Interventions

pegaptanib sodiumDRUG

Intravitreal injection of 0.3 mg every 6 weeks

sham injectionOTHER

sham injection every 6 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type I, or Type II diabetic subjects * Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive Exclusion Criteria: * Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months * HbA1C level \>12% or recent signs of uncontrolled diabetes * Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy

Locations (43)

Outcomes

Primary Outcomes

Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase

Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Time frame: Baseline and Week 24

Secondary Outcomes

Change From Baseline in Visual Acuity (VA): Double Masked Phase

Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts

Time frame: Baseline, Weeks 6, 12, 18, and 24

Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase

Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.

Time frame: Up to 24 weeks

Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase

Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Time frame: Baseline and Week 54

Change From Baseline in Visual Acuity (VA): Open Phase

Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Time frame: Baseline, Weeks 30, 36, 42, 48 and 54

Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase

Data from ClinicalTrials.gov

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Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Akita University Hospital

Akita, Akita, Japan

Aomori Prefectural Chuo Hospital

Aomori, Aomori, Japan

Chiba University Hospital

Chiba, Chiba, Japan

Juntendo University Hospital Urayasu, Ophthalmology

Urayasu-shi, Chiba, Japan

Hayashi Eye Hospital

Fukuoka, Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Murakami Karindo Hospital

Fukuoka, Fukuoka, Japan

...and 33 more locations