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

Study Overview
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Brief Summary
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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.

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

Official Title
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A Phase 3, Randomized, Controlled, Double-Masked, Multi-Center, Comparative, In Parallel Groups (For 24 Weeks), To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium, With Sham Injections, And Open Study (For 30 Weeks) To Confirm The Safety Of 0.3 MG Pegaptanib Sodium In Subjects With Diabetic Macular Edema (DME)

Conditions
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Macular Edema, Diabetic Mellitus, Retinal Disease

Intervention / Treatment
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* Drug: pegaptanib sodium
* Other: sham injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pegaptanib sodium<br> | Drug: pegaptanib sodium<br>* Intravitreal injection of 0.3 mg every 6 weeks<br>|
| Sham Comparator: sham injection<br> | Other: sham injection<br>* sham injection every 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | Baseline, Weeks 30, 36, 42, 48 and 54 | 
| Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase | Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy. | Weeks 24 to 54 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic macular edema, Macugen, sham-controlled study