Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00155

2 Trial Registration Date

2008-02-15

iRegistration Status

Prospective

3 Secondary IDs

Not applicable

4 Source(s) of Funding

N/A

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. Anita SY Ng

ii Address

iii Phone

anitang@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

8Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Dennis SC Lam

ii Address

iii Phone

dennislam_cu_res@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Intravitreal injection of Bevacizumab (Avastin®) as an adjunctive therapy of pterygium surgery to prevent recurrence: A pilot study

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Not applicable

12 Countries of Recruitment

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2008-01-31

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

pterygium

15Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Intravitreal injection of Bevacizumab (Avastin®) after surgical excision of pterygium

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

one injection immediately after surgical excision of pterygium

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

There is no comparative treatment as this is a pilot study. We will observe the recurrence rate of pterygium being treated with adjunctive intravitreal Avastin injection and design a randomized controlled trial in the future.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: 1. Age 18 years or above 2. Eye with single-head primary or secondary pterygium 3. Patient able and willing to give informed consent to the pterygium surgery with intravitreal injections of bevacizumab Exclusion criteria: 1. Single functional eye 2. Pregnant patients 3. Use of anticoagulants or antiplatelet therapy other than aspirin / NSAID within 14 days of surgery.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-03-01

21 Target Sample Size

50 eyes

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Recurrence of pterygium, up to 24 months post op

24 Secondary Outcome

- Visual acuity (VA) - Intraocular pressure (IOP) - Corneal endothelial cell counts - Corneal astigmatism - Any complications from the injections

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2012-04-17

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2008-02-15