GlaucomaPhase 2/3NCT00626782
Lucentis Versus Mitomycin C During Glaucoma Surgery
A Phase 2/3 study testing Ranibizumab and Mitomycin (MMC) in people with Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Ranibizumab and Mitomycin (MMC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 yrs or older
- patients requiring first time glaucoma filtering surgery
- phakic or pseudophakic
- must provide written informed consent and comply with study assignments
Who cannot join
- Pregnant, lactation or premenopausal women not using adequate contraception.
- Previous glaucoma surgery, tube shunt surgery, pars plana vitrectomy, scleral buckle, penetrating keratoplasty.
- Abnormality preventing reliable applanation tonometry in each eye.
- Current infection or inflammation in either eye.
- Enrolled in another investigational study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital, Glaucoma Service
Philadelphia, Pennsylvania, 19107
About this study
Official title: Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery
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.
Read the detailed description
This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied.
Post operative follow-up will consist of a minimum of 6 visits during a one year period.
- Conditions
- Glaucoma
- Being tested
- Ranibizumab, Mitomycin (MMC)
- Keywords
- glaucoma, glucoma filtering surgery, ranibizumab, mitomycin C, patients requiring first time glaucoma filtering surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
Mitomycin (MMC)Drug
Also called MMC C 0.4 mg/ml
Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
| Study group | Role | What they receive |
|---|---|---|
| A: Ranibizumab 0.5mg (0.05mL) injection | Experimental | 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. Receives: Drug: Ranibizumab |
| B: Mitomycin C 0.4 mg/ml sponge | Active comparator | 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. Receives: Drug: Mitomycin (MMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.
Measured: 12 months
Secondary outcomes (1)
Post-Operative Requirement for Glaucoma Medication
Mean number of glaucoma medications used by each participant over the course of one year post-operatively.
Measured: 1 day, 2 wks, 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Michael Pro, Wills Eye
- Investigators
- Michael J Pro, MD, Principal investigator, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626782
- Sponsor's protocol ID
- IRB#07-819
- Other IDs
- rhuFAB v2
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2008
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pro MJ, Freidl KB, Neylan CJ, Sawchyn AK, Wizov SS, Moster MR. Ranibizumab versus mitomycin C in primary trabeculectomy--a pilot study. Curr Eye Res. 2015 May;40(5):510-5. doi: 10.3109/02713683.2014.935441. Epub 2014 Jul 14.
PubMed 25019269
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery
- ClinicalTrials.gov ID
- NCT00626782
- Acronym / sponsor ID
- IRB#07-819
- Conditions
- Glaucoma
- Keywords
- glaucoma, glucoma filtering surgery, ranibizumab, mitomycin C, patients requiring first time glaucoma filtering surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Genentech, Inc., Novartis Pharmaceuticals
- Study start
- Jan 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 13 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied.
Post operative follow-up will consist of a minimum of 6 visits during a one year period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
| Arm | Type | Receives |
|---|---|---|
| A: Ranibizumab 0.5mg (0.05mL) injection | Experimental | Drug: RanibizumabRanibizumab 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. |
| B: Mitomycin C 0.4 mg/ml sponge | Active comparator | Drug: Mitomycin (MMC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 yrs or older
- patients requiring first time glaucoma filtering surgery
- phakic or pseudophakic
- must provide written informed consent and comply with study assignments
Key exclusion criteria (5 listed)
- Pregnant, lactation or premenopausal women not using adequate contraception.
- Previous glaucoma surgery, tube shunt surgery, pars plana vitrectomy, scleral buckle, penetrating keratoplasty.
- Abnormality preventing reliable applanation tonometry in each eye.
- Current infection or inflammation in either eye.
- Enrolled in another investigational study.
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 |
|---|---|---|
| RanibizumabAlso: LucentisRanibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery | Drug | A: Ranibizumab 0.5mg (0.05mL) injection |
| Mitomycin (MMC)Also: MMC C 0.4 mg/mlMitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery. | Drug | B: Mitomycin C 0.4 mg/ml sponge |
Primary outcome
Adverse Events
Time frame: 12 months
Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.
1 secondary outcome
Post-Operative Requirement for Glaucoma Medication
Time frame: 1 day, 2 wks, 1, 3, 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25019269Pro MJ, Freidl KB, Neylan CJ, Sawchyn AK, Wizov SS, Moster MR. Ranibizumab versus mitomycin C in primary trabeculectomy--a pilot study. Curr Eye Res. 2015 May;40(5):510-5. doi: 10.3109/02713683.2014.935441. Epub 2014 Jul 14.
- 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.
Michael J Pro, MD principal investigator
Wills Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ranibizumab and Mitomycin (MMC) in people with Glaucoma, run by Wills Eye at 1 site in United States.
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 4 inclusion and 5 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 22 Mar 2018. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00626782, which also lists 1 linked publication.
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 22 Mar 2018.