Open Angle GlaucomaNCT03548805
Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma
A study testing ologen® Collagen Matrix and Trabeculectomy with low dose mitomycin C in people with Open Angle Glaucoma, run by L.V. Prasad Eye Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- ologen® Collagen Matrix and Trabeculectomy with low dose mitomycin C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 16 Aug 2018to 19 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 10 to 40 years (inclusive)
- Uncontrolled IOP (defined as IOP > 21 mm Hg) despite maximum tolerable antiglaucoma therapy
- Open anterior chamber angle on gonioscopic examination
- 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
- Patientor his/her guardian is willing and able to comply with study procedures and sign informed consent
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Open Angle Glaucoma
- Being tested
- ologen® Collagen Matrix, Trabeculectomy with low dose mitomycin C
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ologen® Collagen MatrixProcedure or surgery
Ologen is a collagen matrix used to modulate wound healing in the postoperative period to promote diffuse blebs
Trabeculectomy with low dose mitomycin CProcedure or surgery
Trabeculectomy with low dose MMC
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy with Ologen | Experimental | ologen® Collagen Matrix Receives: Procedure: ologen® Collagen Matrix |
| Trabeculectomy with low dose mitomycin C | Active comparator | Trabeculectomy with low dose MMC (0.02%) Receives: Procedure: Trabeculectomy with low dose mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure control in the two groups will be compared.
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.
Measured: 1 year
Secondary outcomes (1)
Bleb morphology:Change of Moorfields Bleb Grading System (MBGS) score over time
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
Measured: at 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start16 Aug 2018
- Primary completion1 Apr 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- L.V. Prasad Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HERF, L.V. Prasad Eye Institute
- Investigators
- Senthil Sirisha, MS, Principal investigator, YES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548805
- Sponsor's protocol ID
- IIS-90616
- Status last verified
- Dec 2023
- First submitted
- 16 Mar 2018
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03548805
- Acronym / sponsor ID
- IIS-90616
- Conditions
- Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- L.V. Prasad Eye InstituteUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ologen® Collagen Matrix, Model 830601, shape Round cylindrical, Size 6mm (diameter) x 2mm (thickness),Manufacturer Aeon Astron Europe B. V.
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy with Ologen | Experimental | Procedure: ologen® Collagen Matrixologen® Collagen Matrix |
| Trabeculectomy with low dose mitomycin C | Active comparator | Procedure: Trabeculectomy with low dose mitomycin CTrabeculectomy with low dose MMC (0.02%) |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 10 to 40 years (inclusive)
- Uncontrolled IOP (defined as IOP > 21 mm Hg) despite maximum tolerable antiglaucoma therapy
- Open anterior chamber angle on gonioscopic examination
- 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
- Patientor his/her guardian is willing and able to comply with study procedures and sign informed consent
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ologen® Collagen MatrixOlogen is a collagen matrix used to modulate wound healing in the postoperative period to promote diffuse blebs | Procedure or surgery | Trabeculectomy with Ologen |
| Trabeculectomy with low dose mitomycin CTrabeculectomy with low dose MMC | Procedure or surgery | Trabeculectomy with low dose mitomycin C |
Primary outcome
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.
1 secondary outcome
Bleb morphology:Change of Moorfields Bleb Grading System (MBGS) score over time
Time frame: at 3 months, 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senthil Sirisha, MS principal investigator
YES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ologen® Collagen Matrix and Trabeculectomy with low dose mitomycin C in people with Open Angle Glaucoma, run by L.V. Prasad Eye Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure control in the two groups will be compared. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.