Clinical trial NCT03548805: Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma
Official title: Randomized Controlled Study to Evaluate Safety and Efficacy of Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Lead sponsor: L.V. Prasad Eye Institute
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ologen® Collagen Matrix, Model 830601, shape Round cylindrical, Size 6mm (diameter) x 2mm (thickness),Manufacturer Aeon Astron Europe B. V.
Primary purpose: TREATMENT

Brief summary: To the best of Investigator knowledge, no studies to this date have compared the safety and efficacyof ologen® Collagen Matrix to MMC in exaggerated healing response among JOAG patients. Given that,filtration surgery is usually less successful in patients with juvenile glaucoma; the purpose of this study is to compare these two adjuvant therapies in exaggerated healing response among JOAG patients. Investigator hypothesis is that trabeculectomy with ologen® Collagen Matrix would be as effective as MMC in IOP control, with prominent bleb morphology as compared to MMC bleb.

Detailed description: Standard trabeculectomy All trabeculectomy surgeries will be performed under peribulbar anesthesia.Under aseptic surgical technique, superior rectus suture will be placed using 4-0 silk and a fornix-based conjunctival flap will be performed. Sub-Tenon dissection and hemostasis may be performed as required.A half-thickness 4 x 4mm rectangular/ triangular scleral flap will be dissected up to clear cornea, and a 2 × 2 mm deep scleral block will be excised and peripheral iridectomy will be performed. The scleral flap will be closed with one or two 10-0 nylon sutures and conjunctiva will be closed with 8-0 vicryl suture. Releasable sutures may be applied to the scleral flap if needed.

ologen® Collagen Matrix ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 (valid till Mar-15-2018) will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.

The following table summarizes the model number, shape and manufacturer of ologen® Collagen Matrix to be used in this clinical research.

Product Model Shape Size Manufacturer Country of Origin Product Registration ologen® Collagen Matrix 830601 Round cylindrical 6mm (diameter) x 2mm (thickness) Aeon Astron Europe B. V. The Netherlands MD-1517 (valid till Mar-15-2018)

Mitomycin C Mitomycin-C Kyowa®; Kyowa Hakko Kogyo Co., Ltd. will be used. 0.02% solution of MMC will be prepared freshly on the day of planned surgery.

Eligibility criteria: Inclusion Criteria:

1. Age between 10 to 40 years (inclusive)
2. Uncontrolled IOP (defined as IOP \> 21 mm Hg) despite maximum tolerable antiglaucoma therapy
3. Open anterior chamber angle on gonioscopic examination
4. Glaucomatous optic disc damage on clinical examination (focal or diffuse neuroretinal rim thinning, localized notching or nerve fiber layer defects) with corresponding visual field (VF) defects
5. Patientor his/her guardian is willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

1. Patients with steroid-induced glaucoma and other types of secondary open angle glaucoma 2. Juvenile-onset Open Angle Glaucoma eyes that underwent trabeculectomy with MMC or had a previous filtering surgery 3. Patients with any other ocular disease that may expose them to an undue risk of a significant adverse event during the course of the study, including but not limited to ocular cancer, trauma, corneal surface damage or other conditions as determined by the clinical judgment of the investigator 4. Patient with single functional eye 5. Participation in any study 30 days prior to trabeculectomy 6. Pregnant or breast-feeding women

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Primary outcomes:
measure: Intraocular pressure control in the two groups will be compared.
timeFrame: 1 year
Secondary outcomes:
measure: Bleb morphology:Change of Moorfields Bleb Grading System (MBGS) score over time
timeFrame: at 3 months, 6 months and 1 year
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: L V Prasad Eye Institute
state: Telangana
Study officials:
affiliation: YES
name: Senthil Sirisha, MS
role: PRINCIPAL_INVESTIGATOR
References: