Trial Outcomes & Findings for Effect of Ranibizumab on Malignant Conjunctival Neoplasia (NCT NCT00456495)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

5 participants

Primary outcome timeframe

2 years

Results posted on

2017-07-21

Participant Flow

Five consecutive subjects were enrolled over an 18-month period in a single ophthalmic oncology center.

There was a single ARM in this study. Subconjunctival 0.5 mg ranibizumab was given as intervention every 2-4 weeks.

Participant milestones

Participant milestones
Measure	Squamous Carcinoma of Conjunctiva Subconjunctival 0.5 mg ranibizumab
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Squamous Carcinoma of Conjunctiva Subconjunctival 0.5 mg ranibizumab
Overall Study Physician Decision	2

Baseline Characteristics

Effect of Ranibizumab on Malignant Conjunctival Neoplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Squamous Carcinoma of Conjunctiva n=5 Participants Subconjunctival 0.5 mg ranibizumab
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	53 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Analysis was per protocol. Treatment was delivered every 2-4 weeks with good 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).

Outcome measures

Outcome measures
Measure	Open Label Treatment n=5 Participants Patients will receive treatment every 2-4 weeks
Number of Patients Assessed for Safety and Tolerability	5 participants

SECONDARY outcome

Timeframe: 2 years

To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate tumor volume, from baseline to month 12, and 24. To report on the number of patients with improvement in tumor volume.

Outcome measures

Outcome measures
Measure	Open Label Treatment n=5 Participants Patients will receive treatment every 2-4 weeks
Evaluating Tumor Destruction or Reduction	5 Participants

Adverse Events

Squamous Carcinoma of Conjunctiva

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinic Coordinator

The New York Eye Cancer Center

Phone: 212-832-8170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place