NCT00456495

Brief Summary

The purpose of this study is to test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and severity of adverse events. Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant conjunctival neoplasia by evaluating tumor destruction or reduction as documented by slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2007

Typical duration 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

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
3.4 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
2.8 years until next milestone

Results Posted

Study results publicly available

June 6, 2013

Completed
Last Updated

July 21, 2017

Status Verified

June 1, 2017

Enrollment Period

3.5 years

First QC Date

April 3, 2007

Results QC Date

April 12, 2011

Last Update Submit

June 21, 2017

Conditions

Conjunctival Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Assessed for Safety and Tolerability

    To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia - using comparative slit lamp examination \[anterior segment and ocular adnexal examination for adverse events (eg abrasion, melting), visual acuity (number of patients with decrease in visual acuity), and blood pressure at each visit (number of patients with increased blood pressure from baseline), and monthly urinalyis (number of patients with abnormal protein level in urine).

    2 years

Secondary Outcomes (1)

  • Evaluating Tumor Destruction or Reduction

    2 years

Study Arms (1)

Subconjunctival ranibizumab

EXPERIMENTAL

Patients will receive subconjunctival ranibizumab every 2-4 weeks.

Drug: ranibizumab

Interventions

ranibizumabDRUG

Subconjunctival injection of drug every 2 to 4 weeks

Also known as: Lucentis
Subconjunctival ranibizumab

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age \> 21 years
  • Tumors whose treatment with standard therapy would cause significant visual morbidity
  • Diagnosis of biopsy proven malignant conjunctival neoplasia and are
  • Recurrent disease
  • Multi-focal disease
  • Diffuse disease

You may not qualify if:

  • Extension of tumor into eye or orbit.
  • Regional spread or metastatic disease
  • Pregnancy (positive pregnancy test) or lactation.
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Current infection or inflammation in either eye
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New York Eye Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Finger PT, Chin KJ. Refractory squamous cell carcinoma of the conjunctiva treated with subconjunctival ranibizumab (Lucentis): a two-year study. Ophthalmic Plast Reconstr Surg. 2012 Mar-Apr;28(2):85-9. doi: 10.1097/IOP.0b013e3182392f29.

    PMID: 22186988RESULT

MeSH Terms

Conditions

Conjunctival Neoplasms

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Eye NeoplasmsNeoplasms by SiteNeoplasmsConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This was a small case series involving a small number of subjects. Further investigations for dose, drug delivery and case selection are warranted.

Results Point of Contact

Title
Clinic Coordinator
Organization
The New York Eye Cancer Center
kchin@eyecancer.com
212-832-8170

Study Officials

  • Paul T. Finger, MD

    The New York Eye Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 5, 2007

Study Start

March 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 21, 2017

Results First Posted

June 6, 2013

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)