NCT01350323

Brief Summary

This is a pilot, prospective, interventional, case-control study investigating aqueous levels of vascular endothelial growth factor (VEGF) in eyes with AMD-related neovascularization treated with intravitreal bevacizumab at the Medical Retina Department, University of Molise, Campobasso.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
Last Updated

May 9, 2011

Status Verified

March 1, 2009

Enrollment Period

1.3 years

First QC Date

May 2, 2011

Last Update Submit

May 6, 2011

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Aqueous VEGF concentration

    To establish if different types of wet-AMD were associated to different concentrations of VEGF at baseline

    Change from baseline of VEGF concentration at month 1

Secondary Outcomes (1)

  • Macular thickness assessment

    Change from baseline of macular thickness at month 1

Study Arms (4)

Type 3 NV

ACTIVE COMPARATOR

Wet-AMD related type 3 neovascularization

Procedure: Aqueous sample

Type 2 NV

ACTIVE COMPARATOR

Wet-AMD related type 2 neovascularization

Procedure: Aqueous sample

Type 1 NV

ACTIVE COMPARATOR

Wet-AMD related type 1 neovascularization

Procedure: Aqueous sample

Controls

OTHER

Aqueous sample (0.1ml) in patients undergoing cataract extraction

Procedure: Aqueous sample

Interventions

Aqueous samplePROCEDURE

Aqueous sample (0.1ml of aqueous)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)

Also known as: Avastin
Type 3 NV

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • wet age-related macular degeneration type 1, 2 or 3

You may not qualify if:

  • BCVA at baseline less than 1.0 logMAR
  • any previous treatment of the neovascular lesion
  • previous vitrectomy
  • laser coagulation within the last 3 months
  • previous participation in any studies using investigational drugs within 3months preceding day 0
  • intraocular surgery (including cataract surgery) in the study eye within 3 months preceding day 0
  • glaucoma in the study eye; diabetes mellitus
  • use of immunosuppressive drugs
  • malignant tumors of any location

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Molise

Campobasso, 86100, Italy

Location

Related Publications (3)

  • Yannuzzi LA, Negrao S, Iida T, Carvalho C, Rodriguez-Coleman H, Slakter J, Freund KB, Sorenson J, Orlock D, Borodoker N. Retinal angiomatous proliferation in age-related macular degeneration. Retina. 2001;21(5):416-34. doi: 10.1097/00006982-200110000-00003.

    PMID: 11642370BACKGROUND

  • Bottoni F, Massacesi A, Cigada M, Viola F, Musicco I, Staurenghi G. Treatment of retinal angiomatous proliferation in age-related macular degeneration: a series of 104 cases of retinal angiomatous proliferation. Arch Ophthalmol. 2005 Dec;123(12):1644-50. doi: 10.1001/archopht.123.12.1644.

    PMID: 16344434BACKGROUND

  • Wells JA, Murthy R, Chibber R, Nunn A, Molinatti PA, Kohner EM, Gregor ZJ. Levels of vascular endothelial growth factor are elevated in the vitreous of patients with subretinal neovascularisation. Br J Ophthalmol. 1996 Apr;80(4):363-6. doi: 10.1136/bjo.80.4.363.

    PMID: 8703891BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Roberto dell'Omo, MD

    University of Molise

    PRINCIPAL INVESTIGATOR

  • Ciro Costagliola, Professor

    University of Molise

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 9, 2011

Study Start

May 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 9, 2011

Record last verified: 2009-03

Locations

IT(1)