Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the submacular space instead of vitreous body in cases when previous state-of-the-art treatment for the AMD was deemed ineffective.

Official Title
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Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA)

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Pegaptanib (Macugen®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 50 years and older with neovascular AMD proven by FA Patients who at baseline Have a BCVA letter score in the study eye between 20/40 to 20/320 using an ETDRS chart measured at 4 meters or Snellen equivalent Have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography: Evidence that CNV extends under the geometric center of the foveal avascular zone. Previous state-of-the-art therapy for the disease is deemed ineffective with following characteristics are given: Loss of visual acuity (2 or more Snellen lines) in the previous 3 months defined as either OR ≥10% increase in the lesion diameter as assessed by fluorescein angiography in the previous 3 months Ability of subject to understand character and individual consequences of clinical trial. Signed and dated informed consent of the subject must be available before start of any specific trial procedures. Women with childbearing potential practicing a medically accepted contraception (negative pregnancy test result, serum or urine at trial entry). Exclusion Criteria: Subjects presenting with any of the following criteria will not be included in the trial: Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, retinal vessel occlusion) Had previous vitrectomy surgery for whatsoever reason Are not pseudophakic Have a >50% area of scarring of the whole CNV lesion size as seen in FA Arterial hypertension refractory to medical treatment Pregnancy and lactation. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. Participation in other clinical trials during the present clinical trial or within the last 3 months. Medical or psychological condition that would not permit completion of the trial or signing of informed consent. Suspected or present ocular or periocular infection

Ages Eligible for Study
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Minimum Age: 50 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegaptanib (Macugen®)|Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks |  | 54 weeks | 
| Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks |  | week 24 and 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks |  | 54 weeks | 
| Mean change from baseline in at week 12 and 24 |  | week 12 and 24 | 
| Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54 |  | week 24 and 54 | 
| Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54 |  | week 24 and 54 | 
| Change in area of leakage at 12, 24 and 54 weeks |  | weeks 12, 24 and 54 | 
| Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks |  | weeks 12, 24 and 54 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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age-related macular degeneration, subretinal injection, Pegaptanib, Macugen