Trial Outcomes & Findings for Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema (NCT NCT02032238)

NCT ID: NCT02032238

Last Updated: 2017-08-11

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-08-11

Participant Flow

Participant milestones

Measure	Laser Photocoagulation With Bevacizumab Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner	Bevacizumab, no Laser Photocoagulation patients receive Anti-VEGF injections (Bevacizumab) only
Overall Study STARTED	12	0
Overall Study COMPLETED	10	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Laser Photocoagulation With Bevacizumab Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner	Bevacizumab, no Laser Photocoagulation patients receive Anti-VEGF injections (Bevacizumab) only
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema

Baseline characteristics by cohort

Measure	Combination With Navigated Laser n=12 Participants Combining photocoagulation and Anti-VEGF Injections in a pre-defined manner Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner Anti-VEGF Injections: Monotherapy	Monotherapy patients receive Anti-VEGF Monotherapy Anti-VEGF Injections: Monotherapy	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	—	6 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	—	6 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	—	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Combination With Navigated Laser n=10 Participants Combining photocoagulation and Anti-VEGF Injections in a pre-defined manner Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner Anti-VEGF Injections: Monotherapy	Monotherapy patients receive Anti-VEGF Monotherapy Anti-VEGF Injections: Monotherapy
Percentage of Eyes That Received Retreatment	55.56 Percentage of eyes that received retreat	—

Adverse Events

Laser Photocoagulation With Bevacizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bevacizumab, no Laser Photocoagulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ulrike Weber

OD-OS GmbH

Phone: +49 332831282

Email: ulrike.weber@od-os.com

Results disclosure agreements

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

Restriction type: LTE60