NCT00788177

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 27, 2011

Status Verified

July 1, 2009

Enrollment Period

3.3 years

First QC Date

November 7, 2008

Last Update Submit

September 26, 2011

Conditions

Age-related Macular Degeneration

Keywords

age-related macular degenerationsubretinal injectionPegaptanibMacugen

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Pegaptanib (Macugen®)DRUG

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

Also known as: Macugen®, Pfizer Pharma GmbH

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Ludwigshafen hospital

Ludwigshafen, 67063, Germany

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Lars-Olof Hattenbach, MD

    Department of ophthalmology, Ludwigshafen hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars-Olof Hattenbach, MD

CONTACT

+49 (621) 503 3051hattenbl@klilu.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 10, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

September 27, 2011

Record last verified: 2009-07

Locations

DE(1)