Trial Outcomes & Findings for Lucentis Versus Mitomycin C During Glaucoma Surgery (NCT NCT00626782)

NCT ID: NCT00626782

Last Updated: 2018-03-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2018-03-22

Participant Flow

Participant milestones

Measure	Treatment 1 (Ranibizumab 0.5mg) 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	Treatment 2 (Mitomycin C 0.4 mg/ml) 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.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lucentis Versus Mitomycin C During Glaucoma Surgery

Baseline characteristics by cohort

Measure	Treatment 1 (Ranibizumab 0.5mg) n=12 Participants 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	Treatment 2 (Mitomycin C 0.4 mg/ml) n=12 Participants 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 n=24 Participants Total of all reporting groups
Age, Continuous	67 Years n=5 Participants	68.5 Years n=7 Participants	67.75 Years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment 1 (Ranibizumab 0.5mg) n=12 Participants 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	Treatment 2 (Mitomycin C 0.4 mg/ml) n=12 Participants 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.
Adverse Events	100 percentage of participants	16.67 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment 1 (Ranibizumab 0.5mg) n=12 Participants 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	Treatment 2 (Mitomycin C 0.4 mg/ml) n=12 Participants 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.
Post-Operative Requirement for Glaucoma Medication 1 Day	0.01 number of glaucoma medications used Interval 0.0 to 0.2	0.0 number of glaucoma medications used Interval 0.0 to 0.05
Post-Operative Requirement for Glaucoma Medication 2 wks	0.0 number of glaucoma medications used Interval 0.0 to 0.11	0.01 number of glaucoma medications used Interval 0.0 to 0.1
Post-Operative Requirement for Glaucoma Medication 1 month	0.13 number of glaucoma medications used Interval 0.0 to 0.46	0.01 number of glaucoma medications used Interval 0.0 to 0.1
Post-Operative Requirement for Glaucoma Medication 3 months	0.66 number of glaucoma medications used Interval 0.22 to 1.33	0.08 number of glaucoma medications used Interval 0.0 to 0.26
Post-Operative Requirement for Glaucoma Medication 6 months	0.34 number of glaucoma medications used Interval 0.05 to 0.89	0.06 number of glaucoma medications used Interval 0.0 to 0.24
Post-Operative Requirement for Glaucoma Medication 12 months	0.15 number of glaucoma medications used Interval 0.0 to 0.57	0.06 number of glaucoma medications used Interval 0.0 to 0.22

Adverse Events

Treatment 1 (Ranibizumab 0.5mg)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Treatment 2 (Mitomycin C 0.4 mg/ml)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment 1 (Ranibizumab 0.5mg) n=12 participants at risk 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	Treatment 2 (Mitomycin C 0.4 mg/ml) n=12 participants at risk 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.
Eye disorders optic nerve swelling	16.7% 2/12 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.	0.00% 0/12 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.
Eye disorders choroidal detachment	25.0% 3/12 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.	8.3% 1/12 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.
Eye disorders choroidal folds	8.3% 1/12 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.	0.00% 0/12 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.
Eye disorders macular/retinal folds	8.3% 1/12 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.	0.00% 0/12 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.
Eye disorders needling of the bleb	41.7% 5/12 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.	8.3% 1/12 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.

Additional Information

Prinicipal Investigator

Wills Eye Hospital

Phone: 484-434-2700

Email: mpro2020@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place