A: Ranibizumab 0.5mg (0.05mL) injection for Glaucoma

Phase 2 & 3

Waitlist Available

Led By Michael J Pro, MD

Research Sponsored by Wills Eye

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include late bleb leaks, hypotony and infection.

Eligible Conditions

Glaucoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Secondary study objectives

Post-Operative Requirement for Glaucoma Medication

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: A: Ranibizumab 0.5mg (0.05mL) injectionExperimental Treatment1 Intervention

Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent.

Group II: B: Mitomycin C 0.4 mg/ml spongeActive Control1 Intervention

Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ranibizumab

FDA approved

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