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Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma

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ClinicalTrials.gov Identifier: NCT03548805
Recruitment Status : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Sirisha Senthil, L.V. Prasad Eye Institute

Tracking Information
First Submitted Date  ICMJE March 16, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date August 8, 2018
Estimated Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
Intraocular pressure control in the two groups will be compared. [ Time Frame: 1 year ]
Comparison of IOP control between the two groups: Assess control of IOP over time. "Complete success" is defined as IOP reduction of >20% and / or an IOP constantly <21 mmHg without any antiglaucoma medication. "Qualified success" is defined as IOP < 21 mmHg with topical antiglaucoma medication. "Failure" is defined as IOP > 21mmHg in 2 subsequent follow visits despite topical antiglaucoma medication.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03548805 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
Bleb morphology:Change of Moorfields Bleb Grading System (MBGS) score over time [ Time Frame: at 3 months, 6 months and 1 year ]
Assess bleb characteristics using Moorfields Bleb Grading System (MBGS) score as measurement tool to document bleb grading score over time; and comparison of bleb morphology in the two groups with photographs and ASOCT
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma
Official Title  ICMJE Randomized Controlled Study to Evaluate Safety and Efficacy of Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
ologen® Collagen Matrix, Model 830601, shape Round cylindrical, Size 6mm (diameter) x 2mm (thickness),Manufacturer Aeon Astron Europe B. V.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Open Angle Glaucoma
Intervention  ICMJE
  • Procedure: ologen® Collagen Matrix
    Ologen is a collagen matrix used to modulate wound healing in the postoperative period to promote diffuse blebs
  • Procedure: Trabeculectomy with low dose mitomycin C
    Trabeculectomy with low dose MMC
Study Arms  ICMJE
  • Experimental: Trabeculectomy with Ologen
    ologen® Collagen Matrix
    Intervention: Procedure: ologen® Collagen Matrix
  • Active Comparator: Trabeculectomy with low dose mitomycin C
    Trabeculectomy with low dose MMC (0.02%)
    Intervention: Procedure: Trabeculectomy with low dose mitomycin C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2019
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thiruttani Charitha, Msc 040 30612124 charitha@lvpei.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548805
Other Study ID Numbers  ICMJE IIS-90616
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Sirisha Senthil, L.V. Prasad Eye Institute
Study Sponsor  ICMJE L.V. Prasad Eye Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Senthil Sirisha, MS YES
PRS Account L.V. Prasad Eye Institute
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP