Subretinal Macugen® for Neovascular Age-Related Macular Degeneration - Full Text View

Sponsors and Collaborators:	Klinikum Ludwigshafen Pfizer
Information provided by:	Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:	NCT00788177

Purpose

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.

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: Pegaptanib (Macugen®)	Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA)

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:

Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Mean change from baseline in at week 12 and 24 [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]
Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54 [ Time Frame: week 24 and 54 ] [ Designated as safety issue: No ]
Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54 [ Time Frame: week 24 and 54 ] [ Designated as safety issue: No ]
Change in area of leakage at 12, 24 and 54 weeks [ Time Frame: weeks 12, 24 and 54 ] [ Designated as safety issue: No ]
Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks [ Time Frame: weeks 12, 24 and 54 ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788177

Contacts

Contact: Alireza Mirshahi, MD, FEBO	+49 (621) 503 3051	mirshaha@klilu.de
Contact: Lars-Olof Hattenbach, MD	+49 (621) 503 3051	hattenbl@klilu.de

Locations

Germany
Department of Ophthalmology, Ludwigshafen hospital	Recruiting
Ludwigshafen, Germany, 67063
Contact: Alireza Mirshahi, MD +49 (621) 503 3051 Mirshaha@klilu.de
Contact: Lars-Olof Hattenbach, MD +49 (621) 503 3051 Hattenbl@klilu.de
Sub-Investigator: Alireza Mirshahi, MD
Principal Investigator: Lars-Olof Hattenbach, MD

Sponsors and Collaborators

Klinikum Ludwigshafen

Pfizer

Investigators

Principal Investigator:

Lars-Olof Hattenbach, MD

Department of ophthalmology, Ludwigshafen hospital

More Information

Responsible Party:	Department of ophthalmology, Ludwigshafen hospital ( Lars-Olof Hattenbach, MD, Privatdozent )
Study ID Numbers:	AU-06102G
Study First Received:	November 7, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00788177
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum Ludwigshafen:

age-related macular degeneration
subretinal injection
Pegaptanib
Macugen

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 16, 2009