Lucentis Versus Mitomycin C During Glaucoma Surgery

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Wills Eye
Study ID
NCT00626782
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
  • Mitomycin (MMC) — DRUG
    Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.

Study Details

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.

Key Dates

First listed
Feb 29, 2008
Start date
Jan 31, 2008
Status verified
Feb 2018
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A: Ranibizumab 0.5mg (0.05mL) injection
    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.
  • Active Comparator: B: Mitomycin C 0.4 mg/ml sponge
    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.

Primary Outcome Measure

Adverse Events [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wills Eye Hospital, Glaucoma ServicePhiladelphiaPennsylvania19107-

Find similar trials in Philadelphia, PA

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Wills Eye Hospital, Glaucoma Service· Philadelphia, PA

Related Studies