NCT00403325

Brief Summary

The purpose of this study is to examine the effects of Lucentis for active Central Serous Chorioretinopathy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

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

August 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
Last Updated

November 3, 2008

Status Verified

October 1, 2008

First QC Date

November 22, 2006

Last Update Submit

October 31, 2008

Conditions

Central Serous Chorioretinopathy

Keywords

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of chronic central serous retinopathy (CSC)

Secondary Outcomes (5)

  • Mean change in VA compared to baseline at month 6 and month 12

  • Proportion of patients with 20/20 vision at month 6 and 12 as compared to baseline

  • Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12

  • Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12

  • Change in subretinal fluid (as measured by optical coherence tomography) from baseline at month 3, 6, 9 and 12

Interventions

rhuFab V2 [ranibizumab] ( Lucentis )DRUG

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A history of persistent central serous chorioretinopathy present for at least 3 months Best-corrected visual acuity (BCVA) of 20/40 (73 letters on the ETDRS chart) to light perception as measured by ETDRS protocol refraction.
  • No signs of choroidal neovascularization
  • Documented subfoveal fluid by OCT
  • Active leak associated with the subfoveal fluid
  • The ability and willingness to provide written informed consent

You may not qualify if:

  • Prior treatment with laser or PDT
  • Have uncontrolled hypertension
  • Have a history of thromboembolic events including stroke, transient ischemic attacks, and myocardial infarction
  • Have use of or need for continued anticoagulation therapy, except aspirin 325 mg/day.
  • Are receiving or require chronic concomitant therapy with systemic (\> 5 mg) or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for 14 or more consecutive days at any time within 6 months prior to screening
  • Previously vitrectomized eyes.
  • Had allergic reactions to fluorescein dye or lack of venous access.
  • Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc.
  • An anticipated need for ocular surgery during the duration of the trial.
  • Within 1 month prior to screening, have had intra ocular surgeries (including cataract surgery) in the study eye.
  • Intravitreal triamcinolone or bevacizumab in the previous 2 months
  • Uncontrolled glaucoma (IOP \> 24 mmHg) on greater than 3 medications.
  • Within 1 month prior to screening had YAG laser capsulotomy in the study eye
  • Have received any other systemic experimental drug within 12 weeks prior to enrollment.
  • Rubeosis iridis or neovascular glaucoma
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitreous Retina Macula Consultants of New York, P.C.

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Richard F. Spaide, M.D.

    Vitreous Retina Macula Consultants of New York, P.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

August 1, 2006

Last Updated

November 3, 2008

Record last verified: 2008-10

Locations

US(1)