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NCT01115517 · ClinicalTrials.gov registry record · Phase 2

Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

A Phase 2 study of Pterygium, sponsored by The University of Texas Health Science Center, Houston.

Completed
Registry status
Phase 2
Development phase
51
Enrollment target
2
Study locations

NCT01115517: Completed Phase 2 study of Pterygium, sponsored by The University of Texas Health Science Center, Houston.

NCT01115517 is a Phase 2 study of Pterygium that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 51 participants, below the 249-participant average among 3 other Pterygium trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01115517, a Phase 2 study of Pterygium, has completed, sponsored by The University of Texas Health Science Center, Houston.

COMPLETED
Registry status
Phase 2
Development phase
51 participants
Enrollment target
2
Study locations

Study Summary

This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.

Conditions Studied

Interventions

  • DRUG Bevacizumab
  • DRUG Mitomycin C

Study Locations (2)

Texas

  • Lyndon B. Johnson General Hospital - Houston
  • Robert Cizik Eye Clinic - Houston

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2010-10
Est. Completion 2015-07
Phase Phase 2

What the finished NCT01115517 record still lists

NCT01115517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 249-participant average among 3 other Pterygium trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Pterygium appearing as the primary indexed condition, and to 2 interventions - of which Bevacizumab is the first listed.

NCT01115517 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01115517 about?

NCT01115517 is a clinical study titled "Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery". This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical remov...

What is the current status of trial NCT01115517?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2010-10. Estimated completion is 2015-07.

What conditions does trial NCT01115517 study?

This clinical trial studies the following conditions: Pterygium.

What interventions are being tested in trial NCT01115517?

The interventions under investigation include: Bevacizumab (DRUG), Mitomycin C (DRUG).

Who is sponsoring clinical trial NCT01115517?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01115517 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01115517, the US trial registry maintained by the National Library of Medicine. NCT01115517 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.