Glaucoma Clinical Trial
Official title:
Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)
The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.
A common problem after undergoing trabeculectomy surgery to create a bleb (blister or
bubble) to reduce intraocular pressure, is scarring of the opening. This scarring prevents
fluid drainage and interferes with the proper functioning of the bleb. MMC (Mitomycin C) is
usually administered intraoperatively, to reduce scarring and increase filtration. However,
the failure rate of trabeculectomy remains high. Anti-VEGF agents have been used
successfully in cases requiring bleb needling. The purpose of the study is to determine the
safety of the combination of ranibizumab and MMC vs monotherapy MMC in patients with
glaucoma.
This is an open-label, Phase I/II safety study of 30 patients randomized to either treatment
with ranibizumab 0.5 mg intravitreally injected (n=10), combination ranibizumab 0.5mg
intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) or
MMC therapy alone (n=10).
For the ranibizumab groups, a repeat injection of ranibizumab 0.5mg may be given PRN at 1
month if hypervascularity or neovascularization of the conjunctiva exists.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06000865 -
Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE
|
N/A | |
| Recruiting |
NCT06278597 -
Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device
|
N/A | |
| Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
| Recruiting |
NCT03274024 -
The Asia Primary Tube Versus Trab (TVT) Study
|
N/A | |
| Completed |
NCT04552964 -
Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
|
N/A | |
| Recruiting |
NCT01957267 -
Functional and Structural Imaging for Glaucoma
|
||
| Active, not recruiting |
NCT04624698 -
iStent Inject New Enrollment Post-Approval Study
|
N/A | |
| Completed |
NCT04020705 -
The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
|
N/A | |
| Completed |
NCT03150160 -
Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
|
Phase 4 | |
| Not yet recruiting |
NCT05581498 -
Glaucoma Exercise as Medicine Study (GEMS).
|
N/A | |
| Recruiting |
NCT02921568 -
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
|
N/A | |
| Active, not recruiting |
NCT02901730 -
Clinical Study of LPI With Different Laser Wavelengths
|
N/A | |
| Completed |
NCT02955849 -
A Trial of China Laser and Surgery Study Glaucoma in Rural China
|
Early Phase 1 | |
| Recruiting |
NCT02471105 -
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
|
Phase 4 | |
| Recruiting |
NCT02554214 -
Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device
|
N/A | |
| Active, not recruiting |
NCT02390284 -
Stop Retinal Ganglion Cell Dysfunction Study
|
Phase 3 | |
| Completed |
NCT02246764 -
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
| Completed |
NCT02653963 -
Triamcinolone for Ahmed Glaucoma Valve
|
N/A | |
| Completed |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
N/A |