Lucentis Versus Mitomycin C During Glaucoma Surgery

• Sponsor: Wills Eye (Other)
• Overall Status: Completed
• CT.gov ID: NCT00626782
• Collaborator: Genentech, Inc. (Industry), Novartis Pharmaceuticals (Industry)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Ranibizumab; Drug: Mitomycin (MMC)	Phase 2/Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A: Ranibizumab 0.5mg (0.05mL) injection 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.	Drug: Ranibizumab; Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery; Other Names: Lucentis
Active Comparator: B: Mitomycin C 0.4 mg/ml sponge 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.	Drug: Mitomycin (MMC); Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.; Other Names: MMC C 0.4 mg/ml

Outcome Measures

Primary Outcome Measures

1. Adverse Events [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.

Secondary Outcome Measures

1. Post-Operative Requirement for Glaucoma Medication [1 day, 2 wks, 1, 3, 6 and 12 months]

   Mean number of glaucoma medications used by each participant over the course of one year post-operatively.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 yrs or older

• patients requiring first time glaucoma filtering surgery

• phakic or pseudophakic

• must provide written informed consent and comply with study assignments

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wills Eye Hospital, Glaucoma Service	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Wills Eye
• Genentech, Inc.
• Novartis Pharmaceuticals

Investigators

• Principal Investigator: Michael J Pro, MD, Wills Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Pro, Principal Investigator, Wills Eye
• ClinicalTrials.gov Identifier: NCT00626782
• Other Study ID Numbers: IRB#07-819; rhuFAB v2
• First Posted: Feb 29, 2008
• Last Update Posted: Mar 22, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Michael Pro, Principal Investigator, Wills Eye: glaucoma; glucoma filtering surgery; ranibizumab; mitomycin C; patients requiring first time glaucoma filtering surgery
• Additional relevant MeSH terms: Glaucoma; Ranibizumab; Mitomycins; Mitomycin

Study Results

Participant Flow

Arm/Group Title	Treatment 1 (Ranibizumab 0.5mg)	Treatment 2 (Mitomycin C 0.4 mg/ml)
Arm/Group Description	Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery	Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
Period Title: Overall Study
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Treatment 1 (Ranibizumab 0.5mg)	Treatment 2 (Mitomycin C 0.4 mg/ml)	Total
Arm/Group Description	Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery	Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.	Total of all reporting groups
Overall Participants	12	12	24
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]	67	68.5	67.75
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 8.3%	4 33.3%	5 20.8%
>=65 years	11 91.7%	8 66.7%	19 79.2%
Sex: Female, Male (Count of Participants)
Female	6 50%	6 50%	12 50%
Male	6 50%	6 50%	12 50%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Adverse Events
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment 1 (Ranibizumab 0.5mg)	Treatment 2 (Mitomycin C 0.4 mg/ml)
Arm/Group Description	Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery	Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
Measure Participants	12	12
Number [percentage of participants]	100 833.3%	16.67 138.9%

2. Secondary Outcome

Title	Post-Operative Requirement for Glaucoma Medication
Description	Mean number of glaucoma medications used by each participant over the course of one year post-operatively.
Time Frame	1 day, 2 wks, 1, 3, 6 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A: Ranibizumab 0.5mg (0.05mL) Injection	B: Mitomycin C 0.4 mg/ml Sponge
Arm/Group Description	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. Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery	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. Mitomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
Measure Participants	12	12
1 Day	0.01	0.0
2 wks	0.0	0.01
1 month	0.13	0.01
3 months	0.66	0.08
6 months	0.34	0.06
12 months	0.15	0.06

Adverse Events

Adverse Event Reporting Description	At each of the six post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, optic disc swelling, choroidal detachment, choroidal folds, macular/retinal folds, and needing of the bleb.
Arm/Group Title	Treatment 1 (Ranibizumab 0.5mg)		Treatment 2 (Mitomycin C 0.4 mg/ml)
Arm/Group Description	Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery		Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
All Cause Mortality
	Treatment 1 (Ranibizumab 0.5mg)		Treatment 2 (Mitomycin C 0.4 mg/ml)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Treatment 1 (Ranibizumab 0.5mg)		Treatment 2 (Mitomycin C 0.4 mg/ml)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Treatment 1 (Ranibizumab 0.5mg)		Treatment 2 (Mitomycin C 0.4 mg/ml)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/12 (100%)		2/12 (16.7%)
Eye disorders
optic nerve swelling	2/12 (16.7%)		0/12 (0%)
choroidal detachment	3/12 (25%)		1/12 (8.3%)
choroidal folds	1/12 (8.3%)		0/12 (0%)
macular/retinal folds	1/12 (8.3%)		0/12 (0%)
needling of the bleb	5/12 (41.7%)		1/12 (8.3%)

Limitations/Caveats

Small sample size. Different surgical techniques among multiple surgeons.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.