Trial Outcomes & Findings for Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration (NCT NCT02569892)

Results Overview

Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

baseline, 6, 12, and 24 months

Results posted on

2021-10-28

Participant Flow

Participants recruited from January 2016 until May 2018, at which time interim analysis revealed futility.

19 participants signed informed consent; 2 participants failed screening, and 17 participants started the study. Participants may have contributed one or both eyes to the study. If both eyes were enrolled the first eye would be randomly assigned to treatment or sham, and the fellow eye would be assigned to the opposite treatment arm. Participants who contributed more than one eye are counted in more than one reporting group.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Sub-threshold Macular Laser Photocoagulation Participants that receive treatment with sub-threshold macular laser photocoagulation	Sham Laser Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Overall Study STARTED	10 10	9 9
Overall Study COMPLETED	10 10	8 8
Overall Study NOT COMPLETED	0 0	1 1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=17 Participants Participants receive sub-threshold macular laser photocoagulation and/or sham treatment with power setting at zero
Age, Categorical <=18 years	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=17 Participants
Age, Categorical >=65 years	15 Participants n=17 Participants
Sex: Female, Male Female	11 Participants n=17 Participants
Sex: Female, Male Male	6 Participants n=17 Participants
Region of Enrollment United States	17 Participants n=17 Participants

PRIMARY outcome

Timeframe: baseline, 6, 12, and 24 months

Population: Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method.

Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)

Outcome measures

Outcome measures
Measure	Sub-threshold Macular Laser Photocoagulation n=10 Eyes Participants that receive treatment with sub-threshold macular laser photocoagulation	Sham Laser n=9 Eyes Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Change in Macular Drusen Volume Baseline volume	0.05 mm^3 Interval 0.05 to 0.14	0.11 mm^3 Interval 0.07 to 0.13
Change in Macular Drusen Volume 6 month change	20.0 mm^3 Interval 6.04 to 33.3	9.0 mm^3 Interval -55.5 to 25.0
Change in Macular Drusen Volume 12 month change	42.2 mm^3 Interval 25.0 to 55.01	27.2 mm^3 Interval -85.7 to 46.2
Change in Macular Drusen Volume 24 month change	80.0 mm^3 Interval 34.75 to 135.0	-4.5 mm^3 Interval -85.7 to 81.8

SECONDARY outcome

Timeframe: baseline, 6, 12, and 24 months

Population: Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method.

Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart

Outcome measures

Outcome measures
Measure	Sub-threshold Macular Laser Photocoagulation n=10 Eyes Participants that receive treatment with sub-threshold macular laser photocoagulation	Sham Laser n=9 Eyes Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Change in Visual Acuity Baseline vision	81.7 Letters Standard Deviation 8.60	79.4 Letters Standard Deviation 5.19
Change in Visual Acuity 6 month change	-0.7 Letters Standard Deviation 4.24	-3.4 Letters Standard Deviation 4.67
Change in Visual Acuity 12 month change	-2.7 Letters Standard Deviation 324	-0.9 Letters Standard Deviation 3.95
Change in Visual Acuity 24 month change	-3.6 Letters Standard Deviation 6.10	-6.3 Letters Standard Deviation 6.96

SECONDARY outcome

Timeframe: 2 years

Population: Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method.

Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.

Outcome measures

Outcome measures
Measure	Sub-threshold Macular Laser Photocoagulation n=10 Eyes Participants that receive treatment with sub-threshold macular laser photocoagulation	Sham Laser n=9 Eyes Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)	0 Eyes	0 Eyes

Adverse Events

Sub-threshold Macular Laser Photocoagulation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sub-threshold Macular Laser Photocoagulation n=10 participants at risk Participants that receive treatment with sub-threshold macular laser photocoagulation	Sham Laser n=9 participants at risk Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Eye disorders mild supra-threshold laser burns	10.0% 1/10 • Number of events 1 • 24 months Per protocol, only adverse events related to treatment were collected. Participants who contributed more than one eye are counted in more than one reporting group.	0.00% 0/9 • 24 months Per protocol, only adverse events related to treatment were collected. Participants who contributed more than one eye are counted in more than one reporting group.

Additional Information

Steven Sanislo, MD

Stanford University School of Medicine

Phone: 650-723-6995

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place