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Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

Primary Purpose

Age-related Macular Degeneration

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pegaptanib (Macugen®)
Sponsored by
Klinikum Ludwigshafen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring age-related macular degeneration, subretinal injection, Pegaptanib, Macugen

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, Ludwigshafen hospitalRecruiting

Outcomes

Primary Outcome Measures

Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks
Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2008
Last Updated
September 26, 2011
Sponsor
Klinikum Ludwigshafen
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00788177
Brief Title
Subretinal Macugen® for Neovascular Age-Related Macular Degeneration
Official Title
Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Klinikum Ludwigshafen
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
age-related macular degeneration, subretinal injection, Pegaptanib, Macugen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pegaptanib (Macugen®)
Other Intervention Name(s)
Macugen®, Pfizer Pharma GmbH
Intervention Description
Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)
Primary Outcome Measure Information:
Title
Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks
Time Frame
54 weeks
Title
Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks
Time Frame
week 24 and 54
Secondary Outcome Measure Information:
Title
Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks
Time Frame
54 weeks
Title
Mean change from baseline in at week 12 and 24
Time Frame
week 12 and 24
Title
Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54
Time Frame
week 24 and 54
Title
Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54
Time Frame
week 24 and 54
Title
Change in area of leakage at 12, 24 and 54 weeks
Time Frame
weeks 12, 24 and 54
Title
Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks
Time Frame
weeks 12, 24 and 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars-Olof Hattenbach, MD
Phone
+49 (621) 503 3051
Email
hattenbl@klilu.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Olof Hattenbach, MD
Organizational Affiliation
Department of ophthalmology, Ludwigshafen hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Ludwigshafen hospital
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars-Olof Hattenbach, MD
Phone
+49 (621) 503 3051
Email
Hattenbl@klilu.de
First Name & Middle Initial & Last Name & Degree
Lars-Olof Hattenbach, MD

12. IPD Sharing Statement

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Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

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