Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

NCT00788177

Last updated date
Study Location
Department of Ophthalmology, Ludwigshafen hospital
Ludwigshafen, , 67063, Germany
Contact
+49 (621) 503 3051

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+49 (621) 503 3051

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age-related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Age-related Macular DegenerationSubretinal Macugen® for Neovascular Age-Related Macular Degeneration
NCT00788177
  1. Ludwigshafen,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Age-Related Macular DegenerationStudy of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
NCT00725686
  1. Beverly Hills, California
  2. Pasadena, California
  3. Walnut Creek, California
  4. Miami, Florida
  5. Aiea, Hawaii
  6. Baltimore, Maryland
  7. New York, New York
  8. Cleveland, Ohio
  9. Petah Tikva,
  10. Rehovot,
  11. Tel Aviv,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Subretinal Macugen® for Neovascular Age-Related Macular Degeneration
Official Title  ICMJE Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age-related Macular Degeneration
Intervention  ICMJE Drug: Pegaptanib (Macugen®)
Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)
Other Name: Macugen®, Pfizer Pharma GmbH
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 7, 2008)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00788177
Other Study ID Numbers  ICMJE AU-06102G
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lars-Olof Hattenbach, MD, Privatdozent, Department of ophthalmology, Ludwigshafen hospital
Study Sponsor  ICMJE Klinikum Ludwigshafen
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Lars-Olof Hattenbach, MDDepartment of ophthalmology, Ludwigshafen hospital
PRS Account Klinikum Ludwigshafen
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP